§201.66. Format and content requirements for over-the-counter (OTC) drug product labeling. — Inbound Citations

(c) The labeling of the drug must comply with other applicable labeling requirements for nonprescription drug products under this part, including the format and content requirements for nonprescription drug product labeling under § 201.66.

(b) The labeling of OTC vaginal contraceptive and spermicide drug products containing nonoxynol 9 as the active ingredient, whether subject to the ongoing OTC drug review or an approved drug application, must contain the following warnings under the heading “Warnings,” in accordance with 21 CFR 201.66.

(1) “[bullet] For vaginal use only [bullet] Not for rectal (anal) use” [both warnings in bold type].

(2) “Sexually transmitted diseases (STDs) alert [in bold type]: This product does not [word “not” in bold type] protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner”.

(3) “Do not use” [in bold type] if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control”.

(4) “When using this product [in bold type] [optional, bullet] you may get vaginal irritation (burning, itching, or a rash)”.

(5) “Stop use and ask a doctor if [in bold type] [optional, bullet] you or your partner get burning, itching, a rash, or other irritation of the vagina or penis”.

(a) The labeling for all over-the-counter (OTC) drug products containing any internal analgesic/antipyretic active ingredients (including, but not limited to, acetaminophen, aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate) alone or in combination must bear the following labeling in accordance with §§ 201.60, 201.61, and 201.66.

(i) The statement of identity appears in accord with §§ 201.61 and 299.4 of this chapter. The ingredient name “acetaminophen” must appear highlighted (e.g., fluorescent or color contrast) or in bold type, be in lines generally parallel to the base on which the package rests as it is designed to be displayed, and be in one of the following sizes, whichever is greater:

(A) At least one-quarter as large as the size of the most prominent printed matter on the principal display panel (PDP), or

(B) At least as large as the size of the “Drug Facts” title, as required in § 201.66(d)(2). The presence of acetaminophen must appear as part of the established name of the drug, as defined in § 299.4 of this chapter. Combination products containing acetaminophen and a nonanalgesic ingredient(s) (e.g., cough-cold) must include the name “acetaminophen” and the name(s) of the other active ingredient(s) in the product on the PDP in accord with this paragraph. Only the name “acetaminophen” must appear highlighted or in bold type, and in a prominent print size, as described in this paragraph.

(ii) The information required under § 201.66(c)(2) and (c)(3) of this chapter must be included under these headings. The information under these headings, but not the headings, may appear highlighted.

(iii) The labeling of the product states the following warnings under the heading “Warnings”:

(A) This product contains acetaminophen. Severe liver damage may occur if you take [bullet] more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: ‘for this product’] [bullet] with other drugs containing acetaminophen [bullet] 3 or more alcoholic drinks every day while using this product”. This “Liver” warning must be the first warning under the “Warnings” heading. For products that contain both acetaminophen and aspirin, this “Liver” warning must appear after the “Reye's syndrome” and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B) and before the “Stomach bleeding” warning in paragraph (a)(2)(iii)(A) of this section. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning does not need to be included on each blister unit.

(B) “Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.”

(C) “Ask a doctor before use if you have liver disease”.

(D) “Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin” except on the labeling of combination products that contain acetaminophen and NSAID(s).

(A) The labeling of the product states the following warnings under the heading “Warnings”:

(1) The liver warning states “Liver warning [heading in bold type]: This product contains acetaminophen. Severe liver damage may occur if your child takes [bullet] more than 5 doses in 24 hours, which is the maximum daily amount [optional: ‘for this product’] [bullet] with other drugs containing acetaminophen”. This “Liver” warning must be the first warning under the “Warnings” heading. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.

(2) “Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.”

(3) “Ask a doctor before use if your child has liver disease”.

(4) “Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin” except on the labeling of combination products that contain acetaminophen and NSAID(s).

(B) The labeling of the product contains the following information under the heading “Directions”: “this product does not contain directions or complete warnings for adult use” [in bold type].

(v) The labeling of the product states all of the warnings in paragraphs (a)(1)(iii)(A), (a)(1)(iii)(B), and (a)(1)(iii)(C) of this section with the following modifications:

(A) This product contains acetaminophen. Severe liver damage may occur if [bullet] adult takes more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: ‘for this product’] [bullet] child takes more than 5 doses in 24 hours [bullet] taken with other drugs containing acetaminophen [bullet] adult has 3 or more alcoholic drinks everyday while using this product.” If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.

(B) “Ask a doctor before use if the user has liver disease.”

(C) “Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.”

(D) “Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin” except on the labeling of combination products that contain acetaminophen and NSAID(s).

(i) The statement of identity appears in accord with §§ 201.61 and 299.4 of this chapter. The word “(NSAID)” must appear highlighted (e.g., fluorescent or color contrast) or in bold type, be in lines generally parallel to the base on which the package rests as it is designed to be displayed, and be in one of the following sizes, whichever is greater:

(A) At least one-quarter as large as the size of the most prominent printed matter on the PDP, or

(B) At least as large as the size of the “Drug Facts” title, as required in § 201.66(d)(2). The word “(NSAID)” must appear as part of the established name of the drug, as defined in § 299.4 of this chapter, or after the general pharmacological (principal intended) action of the NSAID ingredient. Combination products containing an NSAID and a nonanalgesic ingredient(s) (e.g., cough-cold) must include the name of the NSAID ingredient and the word “(NSAID)” in accordance with this paragraph, and the name(s) of the other active ingredient(s) in the product on the PDP. Only the word “(NSAID)” needs to appear highlighted or in bold type, and in a prominent print size, as described in this paragraph.

(ii) The information required under § 201.66(c)(2) and (c)(3) of this chapter must be included under these headings. The active ingredient(s) section of the product's labeling, as defined in § 201.66(c)(2), contains the term “(NSAID)” after the NSAID active ingredient with an asterisk statement at the end of the active ingredient(s) section that defines the term “NSAID” and states “ nonsteroidal anti-inflammatory drug.” The information under these headings may appear highlighted. However, the headings “Active Ingredient” and “Purpose” may not appear highlighted.

(iii) The labeling of the product states the following warnings under the heading “Warnings”:

(A) This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you [bullet] are age 60 or older [bullet] have had stomach ulcers or bleeding problems [bullet] take a blood thinning (anticoagulant) or steroid drug [bullet] take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) [bullet] have 3 or more alcoholic drinks every day while using this product [bullet] take more or for a longer time than directed”. This “Stomach bleeding” warning must appear after the “Reye's syndrome” and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). For products that contain both acetaminophen and aspirin, the acetaminophen “Liver” warning in paragraph (a)(1)(iii) of this section must appear before the “Stomach bleeding” warning in this paragraph. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.

(B) “Ask a doctor before use if [bullet] stomach bleeding warning applies to you [bullet] you have a history of stomach problems, such as heartburn [bullet] you have high blood pressure, heart disease, liver cirrhosis, or kidney disease [bullet] you are taking a diuretic”.

(C) “Stop use and ask a doctor if [bullet] you experience any of the following signs of stomach bleeding:” [add the following as second level of statements: “[bullet] feel faint [bullet] vomit blood [bullet] have bloody or black stools [bullet] have stomach pain that does not get better”].

(A) The labeling of the product states the following warnings under the heading “Warnings”:

(1) The stomach bleeding warning states “Stomach bleeding warning [heading in bold type]: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child [bullet] has had stomach ulcers or bleeding problems [bullet] takes a blood thinning (anticoagulant) or steroid drug [bullet] takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) [bullet] takes more or for a longer time than directed”. The “Stomach bleeding” warning must appear after the “Reye's syndrome” and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.

(2) “Ask a doctor before use if [bullet] stomach bleeding warning applies to your child [bullet] child has a history of stomach problems, such as heartburn [bullet] child has not been drinking fluids [bullet] child has lost a lot of fluid due to vomiting or diarrhea [bullet] child has high blood pressure, heart disease, liver cirrhosis, or kidney disease [bullet] child is taking a diuretic”.

(3) “Stop use and ask a doctor if [bullet] child experiences any of the following signs of stomach bleeding:” [add the following as second level of statements: [bullet] feels faint [bullet] vomits blood [bullet] has bloody or black stools [bullet] has stomach pain that does not get better”].

(B) The labeling of the product contains the following information under the heading “Directions”: “this product does not contain directions or complete warnings for adult use” [in bold type].

(v) The labeling of the product states all of the warnings in paragraphs (a)(2)(iii)(A) through (a)(2)(iii)(C) of this section with the following modifications:

(A) This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user [bullet] has had stomach ulcers or bleeding problems [bullet] takes a blood thinning (anticoagulant) or steroid drug [bullet] takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) [bullet] takes more or for a longer time than directed [bullet] is age 60 or older [bullet] has 3 or more alcoholic drinks everyday while using this product”. The “Stomach bleeding” warning must appear after the “Reye's syndrome“ and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.

(B) The labeling states “Ask a doctor before use if [bullet] stomach bleeding warning applies to user [bullet] user has history of stomach problems, such as heartburn [bullet] user has high blood pressure, heart disease, liver cirrhosis, or kidney disease [bullet] user takes a diuretic [bullet] user has not been drinking fluids [bullet] user has lost a lot of fluid due to vomiting or diarrhea”.

(C) The labeling states “Stop use and ask a doctor if [bullet] user experiences any of the following signs of stomach bleeding:” [add the following as second level of statements: [bullet] feels faint [bullet] vomits blood [bullet] has bloody or black stools [bullet] has stomach pain that does not get better”].

(8) “Inactive ingredients”, followed by a listing of the established name of each inactive ingredient. If the product is an OTC drug product that is not also a cosmetic product, then the inactive ingredients shall be listed in alphabetical order. If the product is an OTC drug product that is also a cosmetic product, then the inactive ingredients shall be listed as set forth in § 701.3(a) or (f) of this chapter, the names of cosmetic ingredients shall be determined in accordance with § 701.3(c) of this chapter, and the provisions in § 701.3(e), (g), (h), (l), (m), (n), and (o) of this chapter and § 720.8 of this chapter may also apply, as appropriate. If there is a difference in the labeling provisions in this § 201.66 and §§ 701.3 and 720.8 of this chapter, the labeling provisions in this § 201.66 shall be used.

(1) A nonprescription drug product with an ACNU must comply with applicable labeling requirements for nonprescription drug products under this part, including the format and content requirements for nonprescription drug product labeling under § 201.66 and the statements specified in § 201.130(a) and (b).

(3) All text, tables, and figures including the drug facts labeling required by § 201.66 of this chapter.

(1) The product is labeled in compliance with chapter V of the Federal Food, Drug, and Cosmetic Act (the act) and subchapter C et seq. of this chapter, including the format and content requirements in § 201.66 of this chapter. An OTC drug product that is not in compliance with chapter V and subchapter C, including § 201.66 of this chapter, is subject to regulatory action. For purposes of § 201.61(b) of this chapter, the statement of identity of the product shall be the term or phrase used in the applicable OTC drug monograph established in this part.

(ii) For purposes of this paragraph (30), active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans; and drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance (active ingredient), generally, but not necessarily, in association with one or more other ingredients. (These terms are intended to have the meanings assigned to them in the regulations of the Food and Drug Administration appearing at 21 CFR 201.66 (2001) and 21 CFR 314.3 (2000), respectively.)

(1) For all sunscreen products, the following indication statement must be included under the heading “Uses”: “[Bullet] helps prevent sunburn”. See § 201.66(b)(4) of this chapter for definition of bullet.

(1) The labeling states [select one of the following: “controls” or “relieves”] [select one or both of the following: “diarrhea” or “travelers' diarrhea”]. If both “diarrhea” and “travelers' diarrhea” are selected, each shall be preceded by a bullet in accordance with § 201.66(b)(4) and (d)(4) of this chapter and the heading “Uses” shall be used.

(e) The information described in § 201.66(c) of this chapter shall be printed in accordance with the following specifications.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the information in § 201.66(c)(3) of this chapter may be omitted, and the information in § 201.66(c)(5) and (c)(6) of this chapter may be presented as follows:

(i) The words “Contains salicylate.” may be omitted from the warning in § 335.50(c)(2)(i)(B).

(ii) The subheading “When using this product” in § 335.50(c)(2)(iv) may be omitted.

(iii) The words “continue to” may be omitted from the directions in § 335.50(d)(3).

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(3) of this chapter and the bullet in the warning in § 335.50(c)(1)(i) may be omitted.

(e) The title, headings, subheadings, and information described in § 201.66(c) of this chapter shall be printed in accordance with the following specifications:

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(1), (c)(3), (c)(6), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(e) The title, headings, subheadings, and information described in § 201.66(c) of this chapter shall be printed in accordance with the following specifications:

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the headings and information described in § 201.66(c)(3) and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(4) and (c)(5) may be presented as follows:

(i) The heading and indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] stops bleeding of minor cuts from shaving”.

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(3) and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(f) The title, headings, subheadings, and information described in § 201.66(c) of this chapter shall be printed in accordance with the following specifications:

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(1), (c)(3), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(c) The outside container or wrapper of the retail package, or the immediate container label if there is no outside container or wrapper, shall contain the title, headings, subheadings, and information set forth in paragraphs (c)(1) through (c)(8) of this section, and may contain the information under the heading in paragraph (c)(9) of this section, in the order listed.

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(ii) The information required under § 201.66(c)(2) and (c)(3) of this chapter must be included under these headings. The information under these headings, but not the headings, may appear highlighted.

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(d) Where a cosmetic product is also an over-the-counter drug product, the declaration shall declare the active drug ingredients as set forth in § 201.66(c)(2) and (d) of this chapter, and the declaration shall declare the cosmetic ingredients as set forth in § 201.66(c)(8) and (d) of this chapter.

(ii) The information required under § 201.66(c)(2) and (c)(3) of this chapter must be included under these headings. The information under these headings, but not the headings, may appear highlighted.

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the information in § 201.66(c)(3) of this chapter may be omitted, and the information in § 201.66(c)(5) and (c)(6) of this chapter may be presented as follows:

(i) The words “Contains salicylate.” may be omitted from the warning in § 335.50(c)(2)(i)(B).

(ii) The subheading “When using this product” in § 335.50(c)(2)(iv) may be omitted.

(iii) The words “continue to” may be omitted from the directions in § 335.50(d)(3).

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “astringent.” For products containing the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in § 347.20(b), under the “Purpose” heading identified in § 201.66(c)(3) of this chapter, the labeling of each active ingredient in the product states “Astringent”, which is followed by the statements “ When combined together in water, these ingredients form the active ingredient aluminum acetate. See [the following in bold italic type] Directions.”

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(i) If the purpose of the ACNU is for self-selection, the instructions for the ACNU must appear under the “Use” or “Uses” heading required in § 201.66(c)(4) as the first statement, followed by the other information required in § 201.66(c)(4);

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the headings and information described in § 201.66(c)(3) and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(4) and (c)(5) may be presented as follows:

(i) The heading and indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] stops bleeding of minor cuts from shaving”.

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the information in § 201.66(c)(3) of this chapter may be omitted, and the information in § 201.66(c)(5) and (c)(6) of this chapter may be presented as follows:

(i) The words “Contains salicylate.” may be omitted from the warning in § 335.50(c)(2)(i)(B).

(ii) The subheading “When using this product” in § 335.50(c)(2)(iv) may be omitted.

(iii) The words “continue to” may be omitted from the directions in § 335.50(d)(3).

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the headings and information described in § 201.66(c)(3) and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(4) and (c)(5) may be presented as follows:

(i) The heading and indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] stops bleeding of minor cuts from shaving”.

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter. For products containing only mineral oil in § 347.10(l) or sodium bicarbonate in § 347.10(o), this warning may be omitted if labeling for oral use of the product is also provided.

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(2) The external use only warning in § 201.66(c)(5)(i) of this chapter and the warning in paragraph (c)(1)(i) of this section are not required.

(1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter.

(1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter.

(i) The following shall appear in accordance with § 201.66(c)(5)(ii) of this chapter.

(A) The Reye's syndrome warning in § 201.314(h) of this chapter.

(B) “Allergy alert: Contains salicylate. Do not take if you are [bullet] allergic to salicylates (including aspirin), [bullet] taking other salicylate products”.

(A) This product contains acetaminophen. Severe liver damage may occur if you take [bullet] more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: ‘for this product’] [bullet] with other drugs containing acetaminophen [bullet] 3 or more alcoholic drinks every day while using this product”. This “Liver” warning must be the first warning under the “Warnings” heading. For products that contain both acetaminophen and aspirin, this “Liver” warning must appear after the “Reye's syndrome” and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B) and before the “Stomach bleeding” warning in paragraph (a)(2)(iii)(A) of this section. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning does not need to be included on each blister unit.

(A) This product contains acetaminophen. Severe liver damage may occur if you take [bullet] more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: ‘for this product’] [bullet] with other drugs containing acetaminophen [bullet] 3 or more alcoholic drinks every day while using this product”. This “Liver” warning must be the first warning under the “Warnings” heading. For products that contain both acetaminophen and aspirin, this “Liver” warning must appear after the “Reye's syndrome” and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B) and before the “Stomach bleeding” warning in paragraph (a)(2)(iii)(A) of this section. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning does not need to be included on each blister unit.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(iv) The subheadings in § 201.66(c)(5)(iv) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” contains the warnings in § 347.50(c)(2), (c)(4), and (f)(1)(iii).

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(ii) If the purpose of the ACNU is for actual use, the instructions for the ACNU must appear under the “Directions” heading required in § 201.66(c)(6) as the first direction, followed by the other information required in § 201.66(c)(6); or

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the information in § 201.66(c)(3) of this chapter may be omitted, and the information in § 201.66(c)(5) and (c)(6) of this chapter may be presented as follows:

(i) The words “Contains salicylate.” may be omitted from the warning in § 335.50(c)(2)(i)(B).

(ii) The subheading “When using this product” in § 335.50(c)(2)(iv) may be omitted.

(iii) The words “continue to” may be omitted from the directions in § 335.50(d)(3).

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(c) The labeling of this product states under the “Other information” section of the Drug Facts labeling in accordance with § 201.66(c)(7), “[bullet] when used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS.

(b) The sodium content shall be expressed in milligrams per dosage unit and shall include the total amount of sodium regardless of the source, i.e., from both active and inactive ingredients. The sodium content shall be rounded-off to the nearest whole number. The sodium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7).

(b) The calcium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of calcium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of calcium, milligrams should be used. The calcium content per dosage unit shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The calcium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7).

(b) The magnesium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of magnesium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of magnesium, milligrams should be used. The magnesium content shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The magnesium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7).

(b) The potassium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of potassium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of potassium, milligrams should be used. The potassium content shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The potassium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7).

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), (c)(6), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), and (c)(5) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.

(iii) The “external use only” warning in § 347.50(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The warnings in § 347.50(c)(2), (c)(3), and (c)(4) are not required.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vi) of this chapter may be omitted, provided the information after the heading “Warning” contains the warning in § 347.50(e)(1)(iii).

(v) The warnings in § 201.66(c)(5)(x) of this chapter may be omitted.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the headings and information described in § 201.66(c)(3) and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(4) and (c)(5) may be presented as follows:

(i) The heading and indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] stops bleeding of minor cuts from shaving”.

(ii) The “external use only” warning in § 347.52(c)(1) and in § 201.66(c)(5)(i) of this chapter may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning in § 201.66(c)(5)(x) may be limited to the following: “Keep out of reach of children.” The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) may be omitted, provided the information after the heading “Warning” contains the warnings in this paragraph.

(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:

(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.

(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”

(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.

(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”

(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(d) Where a cosmetic product is also an over-the-counter drug product, the declaration shall declare the active drug ingredients as set forth in § 201.66(c)(2) and (d) of this chapter, and the declaration shall declare the cosmetic ingredients as set forth in § 201.66(c)(8) and (d) of this chapter.

(i) The following terms may be used interchangeably in the labeling of OTC drug products, provided such use does not alter the meaning of the labeling that has been established and identified in an applicable monograph or by regulation. The following terms shall not be used to change in any way the title, headings, and subheadings required under § 201.66(c)(1) through (c)(9) of this chapter:

(1) “Abdominal” or “stomach” (in context only).

(2) “Administer” or “give”.

(3) “Aggravate(s)” or “make(s) worse”.

(4) “Application of this product” or “applying”.

(5) “Are uncertain” or “do not know”.

(6) “Ask” or “consult” or “contact”.

(7) “Asking” or “consulting”.

(8) “Assistance” or “help” or “aid”.

(9) “Associated with” or “due to” or “caused by”.

(10) “Avoid contact with eyes” or “do not get into eyes”.

(11) “Avoid inhaling” or “do not inhale”.

(12) “Before a doctor is consulted” or “without first consulting your doctor” or “consult your doctor before”.

(13) “Beverages” or “drinks”.

(14) “Clean” or “cleanse”.

(15) “Consulting” or “advising”.

(16) “Continue(s)” or “persist(s)” or “is persistent” or “do(es) not go away” or “last(s)”.

(17) “Daily” or “every day”.

(18) “Develop(s)” or “begin(s)” or “occur(s)”.

(19) “Difficulty” or “trouble”.

(20) “Difficulty in urination” or “trouble urinating”.

(21) “Discard” or “throw away”.

(22) “Discontinue” or “stop” or “quit”.

(23) “Doctor” or “physician”.

(24) “Drowsiness” or “the drowsiness effect”.

(25) “Drowsiness may occur” or “you may get drowsy”.

(26) “Enlargement of the” or “an enlarged”.

(27) “Especially in children” or especially children”.

(28) “Exceed” or “use more than” or “go beyond”.

(29) “Exceed recommended dosage” or “use more than directed”.

(30) “Excessive” or “too much”.

(31) “Excitability may occur” or “you may get excited”.

(32) “Experience” or “feel”.

(33) “For relief of” or “relieves”.

(34) “For temporary reduction of” or “temporarily reduces”.

(35) “For the temporary relief of” or “temporarily relieves”.

(36) “For the treatment of” or “treats”.

(37) “Frequently” or “often”.

(38) “Give to” or “use in”.

(39) “Immediately” or “right away” or “directly”.

(40) “Immediately” or “as soon as”.

(41) “Immediately following” or “right after”.

(42) “Improve(s)” or “get(s) better” or “make(s) better”.

(43) “Increased” or “more”.

(44) “Increase your risk of” or “cause”.

(45) “Indication(s)” or “Use(s)”.

(46) “Inhalation” or “puff”.

(47) “In persons who” or “if you” or “if the child”.

(48) “Instill” or “put”.

(49) “Is (are) accompanied by” or “you also have” (in context only) or “(optional: that) occur(s) with”.

(50) “Longer” or “more”.

(51) “Lung” or “pulmonary”.

(52) “Medication(s)” or “medicine(s)” or “drug(s)”.

(53) “Nervousness, dizziness, or sleeplessness occurs” or “you get nervous, dizzy, or sleepless”.

(54) “Not to exceed” or “do not exceed” or “not more than”.

(55) “Obtain(s)” or “get(s)”.

(56) “Passages” or “passageways” or “tubes”.

(57) “Perforation of” or “hole in”.

(58) “Persistent” or “that does not go away” or “that continues” or “that lasts”.

(59) “Per day” or “daily”.

(60) “Presently” or “now”.

(61) “Produce(s)” or “cause(s)”.

(62) “Prompt(ly)” or “quick(ly)” or “right away”.

(63) “Reduce” or “minimize”.

(64) “Referred to as” or “of”.

(65) “Sensation” or “feeling”.

(66) “Solution” or “liquid”.

(67) “Specifically” or “definitely”.

(68) “Take” or “use” or “give”.

(69) “Tend(s) to recur” or “reoccur(s)” or “return(s)” or “come(s) back”.

(70) “To avoid contamination” or “avoid contamination” or “do not contaminate”.

(71) “To help” or “helps”.

(72) “Unless directed by a doctor” or “except under the advice of a doctor” or “unless told to do so by a doctor”.

(73) “Use caution” or “be careful”.

(74) “Usually” or “generally” (in context only).

(75) “You” (“Your”) or “the child” (“the child's”).

(76) “You also have” or “occurs with”.

(77) “When practical” or “if possible”.

(78) “Whether” or “if”.

(79) “Worsen(s)” or “get(s) worse” or “make(s) worse”.

(d) Where a cosmetic product is also an over-the-counter drug product, the declaration shall declare the active drug ingredients as set forth in § 201.66(c)(2) and (d) of this chapter, and the declaration shall declare the cosmetic ingredients as set forth in § 201.66(c)(8) and (d) of this chapter.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(3) of this chapter and the bullet in the warning in § 335.50(c)(1)(i) may be omitted.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(1), (c)(3), (c)(6), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(3) and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(1), (c)(3), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(B) At least as large as the size of the “Drug Facts” title, as required in § 201.66(d)(2). The presence of acetaminophen must appear as part of the established name of the drug, as defined in § 299.4 of this chapter. Combination products containing acetaminophen and a nonanalgesic ingredient(s) (e.g., cough-cold) must include the name “acetaminophen” and the name(s) of the other active ingredient(s) in the product on the PDP in accord with this paragraph. Only the name “acetaminophen” must appear highlighted or in bold type, and in a prominent print size, as described in this paragraph.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(1) The labeling states [select one of the following: “controls” or “relieves”] [select one or both of the following: “diarrhea” or “travelers' diarrhea”]. If both “diarrhea” and “travelers' diarrhea” are selected, each shall be preceded by a bullet in accordance with § 201.66(b)(4) and (d)(4) of this chapter and the heading “Uses” shall be used.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(1), (c)(3), (c)(6), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(3) and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(1), (c)(3), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.

(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required information for drug products, and, as appropriate, cosmetic products, other than information required to appear on a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through (d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the “Use(s)” heading, as set forth in paragraph (c)(4) of this section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in § 330.1(c)(2) of this chapter.

(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.

(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title “Drug Facts (continued)” shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.

(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the ascenders and descenders do not touch.

(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.

(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8) of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.