§330.1. General conditions for general recognition as safe, effective and not misbranded. — Inbound Citations

An over-the-counter antacid product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the following conditions and each of the general conditions established in § 330.1 of this chapter.

An over-the-counter antiflatulent product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the following conditions and each of the general conditions established in § 330.1 of this chapter.

(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in § 330.1.

(a) An over-the-counter antifungal drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter acne drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter antidiarrheal drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter antiemetic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(a) An over-the-counter nighttime sleep-aid drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter stimulant drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(a) An over-the-counter cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(a) An over-the-counter analgesic-antipyretic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part in addition to each of the general conditions established in § 330.1 of this chapter.

(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part in addition to each of the general conditions established in § 330.1.

(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter skin protectant drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter external analgesic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter ophthalmic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(a) An over-the-counter antiperspirant drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter sunscreen drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter anticaries drug product in a form suitable for topical administration to the teeth is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter anthelmintic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1.

(a) An over-the-counter cholecystokinetic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart in addition to each of the general conditions established in § 330.1.

(a) An over-the-counter deodorant drug product for internal use in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter wart remover drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in § 330.1 of this chapter.

(a) An over-the-counter ingrown toenail relief drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter corn and callus remover drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in § 330.1 of this chapter.

(a) An over-the-counter pediculicide drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1 of this chapter.

(a) An over-the-counter dandruff, seborrheic dermatitis, or psoriasis drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in § 330.1 of this chapter.

(c) The labeling of the product states, under the heading “Uses,” the phrases listed in this paragraph (c), as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (c), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to misbranding and the prohibition in section 301(d) of the FD&C Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the FD&C Act.

(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.

(2) For sunscreen products with a Broad Spectrum SPF value of 15 or higher according to the tests in paragraphs (i) and (j) of this section, the labeling may include the following statement in addition to the indication in § 201.327(c)(1): “[Bullet] if used as directed with other sun protection measures (see Directions [in bold italic font]), decreases the risk of skin cancer and early skin aging caused by the sun”.

(3) Any labeling or promotional materials that suggest or imply that the use, alone, of any sunscreen reduces the risk of or prevents skin cancer or early skin aging will cause the product to be misbranded under section 502 of the FD&C Act (21 U.S.C. 352).

(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) The labeling of the product states, under the heading “Indications,” the following: “For the relief of” (optional, any or all of the following:) “heartburn,” “sour stomach,” and/or “acid indigestion” (which may be followed by the optional statement:) “and upset stomach associated with” (optional, as appropriate) “this symptom” or “these symptoms.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) (Select one of the following: “Alleviates or Relieves”) “the symptoms referred to as gas.”

(2) (Select one of the following: “Alleviates” or “Relieves”) (select one or more of the following: “bloating,” “pressure,” “fullness,” or “stuffed feeling”) “commonly referred to as gas.”

(b) The labeling of the product states, under the heading “Indications,” the following: “First aid to help” [select one of the following: “prevent,” (“decrease” (“the risk of” or “the chance of”)), (“reduce” (“the risk of” or “the chance of”)), “guard against,” or “protect against”] [select one of the following: “infection,” “bacterial contamination,” or “skin infection”] “in minor cuts, scrapes, and burns.” Other truthful and nonmisleading statements describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” the indication(s) for each ingredient in the combination, as established in the “Indications” sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) The indications in § 333.150 should be used.

(2) In addition to the required indication identified in § 333.150, the labeling of the product may state, under the heading “Indications,” the following additional indication: “First aid for the temporary relief of” (select one of the following: “pain,” “discomfort,” “pain or discomfort” or “pain and itching”) “in minor cuts, scrapes, and burns.”

(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1)(i) of this section and may contain the additional phrase listed in paragraph (b)(1)(ii) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(i) (Select one of the following: “Treats,” “For the treatment of,” “For effective treatment of,” “Cures,” “For the cure of,” “Clears up,” or “Proven clinically effective in the treatment of”) “most” (select one condition from any one or more of the following groups of conditions:

(A) “Athlete's foot,” athlete's foot (dermatophytosis),” “athlete's foot (tinea pedis),” or “tinea pedis (athlete's foot)”;

(B) “Jock itch,” “jock itch (tinea cruris),” or “tinea cruris (jock itch)”; or

(C) “Ringworm,” “ringworm (tinea corporis),” or “tinea corporis (ringworm).”)

(ii) In addition to the information identified in paragraph (b)(1)(i) of this section, the labeling of the product may contain the following statement: (Select one of the following: “Relieves,” “For relief of,” “For effective relief of,” or “Soothes,”) (select one or more of the following: “Itching,” “scaling,” “cracking,” “burning,” “redness,” “soreness,” “irritation,” “discomfort,” “chafing associated with jock itch,” “itchy, scaly skin between the toes,” or “itching, burning feet”).

(i) (Select one of the following: “Clinically proven to prevent,” “Prevents,” “Proven effective in the prevention of,” “Helps prevent,” “For the prevention of,” “For the prophylaxis (prevention) of,” “Guards against,” or “Prevents the recurrence of”) “most” (select one of the following: “Athlete's foot,” “athlete's foot (dermatophytosis),” “athlete's foot (tinea pedis),” or “tinea pedis (athlete's foot)”) “with daily use.”

(ii) In addition to the information identified in paragraph (b)(2)(i) of this section, the labeling of the product may contain the following statement: “Clears up most athlete's foot infection and with daily use helps keep it from coming back.”

(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section and may contain any of the additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “For the” (select one of the following: “management” or “treatment”) “of acne.”

(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any one or more of the following statements:

(i) (Select one of the following: “Clears,” “Clears up,” “Clears up most,” “Dries,” “Dries up,” “Dries and clears,” “Helps clear,” “Helps clear up,” “Reduces the number of,” or “Reduces the severity of”) (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”) which may be followed by “and allows skin to heal.”

(ii) “Penetrates pores to” (select one of the following: “eliminate most,” “control,” “clear most,” or “reduce the number of”) (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”).

(iii) “Helps keep skin clear of new” (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”).

(iv) “Helps prevent new” (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”) which may be followed by “from forming.”

(v) “Helps prevent the development of new” (select one or more of the following: “acne blemishes,” “acne pimples,” “blackheads,” or “whiteheads”).

(b) The labeling of the product states, under the heading “Use,” one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(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.

(2) The labeling states “helps firm stool within 24 to 48 hours”.

(i) When any additional indications are used, the heading “Uses” shall be used and each listed use shall be preceded by a bullet in accord with § 201.66(b)(4) of this chapter.

(ii) In addition to the indication in paragraph (b)(1) of this section, one or both of the following may be used for products containing bismuth subsalicylate in § 335.10(a): “[bullet] reduces number of bowel movements” “[bullet] helps firm stool”.

(b) The labeling of the product states the following under the heading “Indications,” “For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” one or more of the phrases listed in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) (“Helps you” or “Reduces time to”) “fall asleep if you have difficulty falling asleep.”

(2) “For relief of occasional sleeplessness.”

(3) “Helps to reduce difficulty falling asleep.”

(b) The labeling of the product states, under the heading “Indications,” the following: “Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the Act relating to misbranding and the prohibition in section 301(d) of the Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the Act.

(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “Temporarily” (select one of the following: “relieves,” “alleviates,” “decreases,” “reduces,” or “dries”) “runny nose and” (select one of the following: “relieves,” “alleviates,” “decreases,” or “reduces”) “sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever” (which may be followed by one or both of the following: “or other upper respiratory allergies” or “(allergic rhinitis)”).

(2) “For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever” (which may be followed by one or both of the following: “or other upper respiratory allergies” or “(allergic rhinitis)”).

(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “Temporarily” (select one of the following: “alleviates,” “calms,” “controls,” “decreases,” “quiets,” “reduces,” “relieves,” or “suppresses”) “cough due to” (select one of the following: “minor bronchial irritation” or “minor throat and bronchial irritation”) (select one of the following: “as may occur with,” “associated with,” or “occurring with”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.”

(2) “Temporarily” (select one of the following: “alleviates,” “calms,” “controls,” “decreases,” “quiets,” “reduces,” “relieves,” or “suppresses”) “cough” (select one of the following: “as may occur with,” “associated with,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants”).

(3) In addition to the required information identified in paragraphs (b) (1) and (2) of this section, the labeling of the product may contain any (one or more) of the following statements:

(i) “Cough suppressant which temporarily” (select one of the following: “Alleviates,” “controls,” “decreases,” “reduces,” “relieves,” or “suppresses”) “the impulse to cough.”

(ii) “Temporarily helps you cough less.”

(iii) “Temporarily helps to” (select one of the following: “Alleviate,” “control,” “decrease,” “reduce,” “relieve,” or “suppress”) “the cough reflex that causes coughing.”

(iv) “Temporarily” (select one of the following: “Alleviates,” “controls,” “decreases,” “reduces,” “relieves,” or “suppresses”) “the intensity of coughing.”

(v) (Select one of the following: “Alleviates,” “Controls,” “Decreases,” “Reduces,” “Relieves,” or “Suppresses”) (select one of the following: “Cough,” “the impulse to cough,” or “your cough”) “to help you” (select one of the following: “Get to sleep,” “sleep,” or “rest”).

(vi) “Calms the cough control center and relieves coughing.”

(vii) (a) “Nonnarcotic cough suppressant for the temporary” (select one of the following: “alleviation,” “control,” “decrease,” “reduction,” “relief,” or “suppression”) “of cough.”

(b) (Select one of the following: “Alleviates,” “Controls,” “Decreases,” “Reduces,” “Relieves,” or “Suppresses”) “cough impulses without narcotics.”

(b) The labeling of the product states the following under the heading “Use”: “for temporary relief of mild symptoms of intermittent asthma: [bullet] 1 wheezing [bullet] tightness of chest [bullet] shortness of breath”. Other truthful and nonmisleading statements, describing only the indication for use that has been established and listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act relating to misbranding and the prohibition in section 301(d) of the Federal Food, Drug, and Cosmetic Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act.

(b) The labeling of the product states, under the heading “Indications,” the following: “Helps loosen phlegm (mucus) and thin bronchial secretions to” (select one or more of the following: “rid the bronchial passageways of bothersome mucus,” “drain bronchial tubes,” and “make coughs more productive”). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section, as appropriate, and may contain any additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraphs (b)(1) and (b)(2) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) (Select one of the following: “For the temporary relief of nasal congestion” or “Temporarily relieves nasal congestion”) (which may be followed by any of the following in paragraphs (b)(1) (i), (ii), and (iii) of this section):

(i) “due to” (select one of the following: “the common cold” or “a cold”).

(ii) “due to” (select one of the following: “hay fever,” “hay fever (allergic rhinitis),” “hay fever or other upper respiratory allergies,” or “hay fever or other upper respiratory allergies (allergic rhinitis)”).

(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any (one or more) of the following statements:

(i) (Select one of the following: “For the temporary relief of” or “Temporarily relieves”) (select one of the following: “stuffy nose,” “stopped up nose,” “nasal stuffiness,” or “clogged up nose.”)

(ii) (Select one of the following: “Reduces swelling of,” “Decongests,” or “Helps clear”) “nasal passages; shrinks swollen membranes.”

(iii) “Temporarily restores freer breathing through the nose.”

(iv) “Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.”

(v) “Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.”

(b) The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination, as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in the applicable OTC drug monographs or listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(i) The labeling for the analgesic-antipyretic ingredients states “[bullet] temporarily relieves [bullet] minor aches and pains [bullet] headache” and “[bullet] temporarily reduces fever”.

(ii) The labeling for the cough-cold ingredient(s) may follow a separate bullet(s) or may be combined with the relieves part of the indication in paragraph (b)(1)(i) of this section.

(i) The labeling for the analgesic-antipyretic ingredients states “[bullet] temporarily relieves [bullet] minor aches and pains [bullet] headache”.

(ii) The indication(s) for the cough-cold ingredient(s) consists of the labeling for antihistamines in § 341.72(b)(1) or (b)(2) and/or nasal decongestants in § 341.80(b)(1)(ii), as appropriate, and the labeling for any other cough-cold combination. This labeling may follow a separate bullet(s) or may be combined with the indication in paragraph (b)(2)(i) of this section.

(3) The labeling states both indications in paragraphs (b)(1) and (b)(2) of this section.

(4) The labeling for the anesthetic-analgesic ingredients in part 356 of this chapter should be used.

(5) The labeling for antitussive ingredients in § 341.74(b) should be used.

(6) The labeling for nasal decongestant ingredients in § 341.80(b) should be used.

(7) In addition to the required information identified in paragraph (b) of this section, the labeling of the combination drug product may contain any of the “other allowable statements” (if any), that are identified in the applicable OTC drug monographs, provided such statements are neither placed in direct conjunction with information required to appear in the labeling nor occupy labeling space with greater prominence or conspicuousness than the required information.

(b) The labeling of the product states, under the heading “Indication,” the following: “For occasional use as an aid to” (which may be followed by: “soften, loosen, and”) “remove excessive earwax.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Use,” the following: “dries water in the ears” (optional, which may be followed by: “and relieves water-clogged ears”) (which may be followed by any or all of the following: “after: [bullet] 1 swimming [bullet] showering [bullet] bathing [bullet] washing the hair”). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) (“For the temporary relief of,” “Gives temporary relief of,” or “Helps relieve the”) (As an option, select one or both of the following: “local” or “anorectal”) [select one or more of the following: “discomfort,” “itching,” or “itching and discomfort,” followed by: “in the perianal area” or “associated with” (select one or more of the following: “hemorrhoids,” “anorectal disorders,” “inflamed hemorrhoidal tissues,” “anorectal inflammation,” “hemorrhoidal tissues,” or “piles (hemorrhoids).”)]

(2) Indications applicable to each active ingredient of the product may be combined to eliminate duplicative words or phrases so that the resulting indication is clear and understandable. In addition to the indication identified in paragraph (b)(1) of this section, the labeling of the product intended for external or intrarectal use may also contain the following indications, as appropriate.

(i) “For the temporary relief of” (select one or more of the following: “pain,” “soreness,” or “burning”).

(A) “Temporarily reduces the swelling associated with” (select one of the following: “irritated hemorrhoidal tissue and other anorectal disorders” or “irritation in hemorrhoids and other anorectal disorders”).

(B) “Temporarily shrinks hemorrhoidal tissue.”

(A) “Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues.”

(B) “Temporarily protects irritated areas.”

(C) “Temporarily relieves burning.”

(D) “Provides temporary relief from skin irritations.”

(E) “Temporarily provides a coating for relief of anorectal discomforts.”

(F) “Temporarily protects the inflamed, irritated anorectal surface” (select one of the following: “to help make bowel movements less painful” or “from irritation and abrasion during bowel movement”).

(G) “Temporarily protects inflamed perianal skin.”

(H) “Temporarily relieves the symptoms of perianal skin irritation.”

(iv) “For the temporary relief of itching associated with moist anorectal conditions.”

(A) “For the temporary relief of” (select one or both of the following: “pain” or “burning”).

(B) “Can help distract from pain.”

(C) “May provide a cooling sensation.”

(A) “Aids in protecting irritated anorectal areas.”

(B) “Temporary relief of” (select one or both of the following: “irritation” or “burning”).

(vii) The indication in paragraph (b)(1) of this section applies.

(b) The labeling of the product states, under the heading “Uses,” one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) The labeling states “temporarily protects minor: [bullet] 1 cuts [bullet] scrapes [bullet] burns”.

(i) (optional: “helps prevent and”) “temporarily protects” (optional: “and helps relieve”) (optional: “chafed,”) “chapped or cracked skin” (optional: “and lips”). This statement may be followed by the optional statement: “helps” (optional: “prevent and”) “protect from the drying effects of wind and cold weather”. [If both statements are used, each is preceded by a bullet.]

(ii) The labeling states (optional: “helps prevent and”) “temporarily protects” (optional: “and helps relieve”) (optional: “chafed,”) “chapped or cracked lips”. This statement may be followed by the optional statement: “helps” (optional: “prevent and”) “protect from the drying effects of wind and cold weather”. [If both statements are used, each is preceded by a bullet.]

(3) The labeling states “dries the oozing and weeping of poison: [bullet] ivy [bullet] oak [bullet] sumac”.

(4) The labeling states “temporarily protects and helps relieve minor skin irritation and itching due to: [select one or more of the following: ‘[bullet] rashes’ ‘[bullet] eczema’ ‘[bullet] poison ivy, oak, or sumac’ ‘[bullet] insect bites’].”

(5) The labeling states “temporarily protects and helps relieve minor skin irritation and itching due to: [bullet] poison ivy, oak, or sumac [bullet] insect bites”.

(6) The labeling states “temporarily protects and helps relieve minor skin irritation”.

(7) The labeling states “temporarily protects and helps relieve minor skin irritation and itching due to: [select one or more of the following: ‘rashes’ or ‘eczema’].” [If both conditions are used, each is preceded by a bullet.]

(b) The labeling of the product states, under the heading “Uses” any of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition of section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “For temporary relief of minor skin irritations due to: [select one or more of the following: ‘poison ivy,’ ‘poison oak,’ ‘poison sumac,’ ‘insect bites,’ ‘athlete's foot,’ or ‘rashes caused by soaps, detergents, cosmetics, or jewelry’].”

(2) “Stops bleeding caused by minor surface cuts and abrasions as may occur during shaving.”

(3) “Relieves minor skin irritations due to: [select one or more of the following: 'insect bites,' 'minor cuts,' or 'minor scrapes'].” [If more than one condition is used, each is preceded by a bullet.]

(b) The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements, describing only the indications for use that have been established in the applicable OTC drug monographs or listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. In addition to the required information identified in this paragraph (b), the labeling of the product may contain any of the “other allowable statements” that are identified in the applicable monographs, provided such statements are neither placed in direct conjunction with information required to appear in the labeling nor occupy labeling space with greater prominence or conspicuousness than the required information.

(1) In addition to any or all of the indications for skin protectant drug products in § 347.50(b)(1), any or all of the allowable indications for external analgesic drug products may be used if the product is labeled for concurrent symptoms.

(2) In addition to any or all of the indications for skin protectant drug products in § 347.50(b)(1), the required indications for first aid antiseptic drug products should be used.

(3) In addition to any or all of the indications for skin protectant drug products in § 347.50(b)(2)(i), the required indications for sunscreen drug products should be used and any or all of the additional indications for sunscreen drug products may be used.

(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(i) “Helps in the prevention of premature ejaculation.”

(ii) “For temporary male genital desensitization, helping to slow the onset of ejaculation.”

(iii) “Helps in temporarily” (select one of the following: “retarding the onset of,” “slowing the onset of,” or “prolonging the time until”) followed by “ejaculation.”

(iv) “For reducing oversensitivity in the male in advance of intercourse.”

(2) [Reserved]

(b) Where applicable, indications in this part applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this part, may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Uses,” the phrase listed in paragraph (b)(1) of this section and may contain any additional phrases listed in paragraphs (b)(2) through (b)(5) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in paragraphs (b)(1) through (b)(5) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “decreases,” “lessens,” or “reduces”] “underarm” [select one of the following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”].

(2) The labeling may state “also [select one of the following: ‘decreases,’ ‘lessens,’ or ‘reduces’] underarm [select one of the following: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”.

(3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state [select one of the following: “all day protection,” “lasts all day,” “lasts 24 hours,” or “24 hour protection”].

(4) For products that demonstrate extra effectiveness (30 percent sweat reduction), the labeling may state “extra effective”.

(5) Products that demonstrate extra effectiveness (30 percent sweat reduction) sustained over a 24-hour period may state the claims in paragraphs (b)(3) and (b)(4) of this section either individually or combined, e.g., “24 hour extra effective protection”, “all day extra effective protection,” “extra effective protection lasts 24 hours,” or “extra effective protection lasts all day”.

(b) The labeling of the product states, under the heading “Uses,” all of the phrases listed in paragraph (b)(1) of this section that are applicable to the product and may contain any of the additional phrases listed in paragraph (b)(2) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(i) “[bullet] 1 helps prevent sunburn [bullet] higher SPF gives more sunburn protection”.

(ii) “[bullet] retains SPF after 40 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”).

(iii) “[bullet] retains SPF after 80 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”).

(2) In addition to the indications provided in paragraph (b)(1) of this section, the following may be used for products containing any ingredient in § 352.10:

(i) Select one or both of the following: [“[bullet]” (select one of the following: “provides minimal,” “provides minimum,” “minimal,” or “minimum”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], or “[bullet] for skin that sunburns minimally”.

(ii) Select one or both of the following: [“[bullet]” (select one of the following: “provides moderate” or “moderate”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], or “[bullet] for skin that sunburns easily”.

(iii) Select one or both of the following: [“[bullet]” (select one of the following: “provides high” or “high”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], or “[bullet] for skin highly sensitive to sunburn”.

(b) The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use that have been established in the applicable OTC drug monographs or listed in this paragraph (b), may also be used, as provided by § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) In addition, the labeling of the product may contain any of the “other allowable statements” that are identified in the applicable monographs.

(2) For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), any or all of the applicable indications for sunscreens in § 352.52(b) and the indication for skin protectants in § 347.50(b)(2)(i) of this chapter should be used. For products marketed as a lip protectant, the indication in § 352.52(f)(1)(ii) should be used.

(b) The labeling of the product states, under the heading “Indication,” the following: “Aids in the prevention of dental (select one of the following: “cavities,” “decay,” “caries (decay),” or “caries (cavities)”). Other truthful and nonmisleading statements, describing only the indication for use that has been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indication,” the following: “For the treatment of pinworms.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” the following: “For the contraction of the gallbladder during diagnostic gallbladder studies.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “An aid to reduce odor from a colostomy or ileostomy.”

(i) “An aid to reduce odor from a colostomy or ileostomy.”

(ii) “An aid to reduce fecal odor due to incontinence.”

(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “For the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface.”

(2) “For the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.”

(b) The labeling of the product states, under the heading “Use,” the following: “for temporary relief of” [select one or both of the following: ‘pain’ or ‘discomfort’] “from ingrown toenails”. Other truthful and nonmisleading statements, describing only the use that has been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section and may contain the additional phrase listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) “For the removal of corns and calluses.”

(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain the following statement: “Relieves pain by removing corns and calluses.”

(b) The labeling of the product states, under the heading “Uses,” the following: “treats head, pubic (crab), and body lice.” Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section and may contain any of the terms listed in paragraph (b)(2) or (b)(3) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) (“For relief of” or “Controls”) “the symptoms of” (select one or more of the following, as appropriate: “dandruff,” “seborrheic dermatitis,” and/or “psoriasis.”)

(2) The following terms or phrases may be used in place of or in addition to the words “For the relief of” or “Controls” in the indications in paragraph (b)(1) of this section: “fights,” “reduces,” “helps eliminate,” “helps stop,” “controls recurrence of,” “fights recurrence of,” “helps prevent recurrence of,” “reduces recurrence of,” “helps eliminate recurrence of,” “helps stop recurrence of.”

(3) The following terms may be used in place of the words “the symptoms of” in the indications in paragraph (b)(1) of this section: (“skin” and/or “scalp,” as appropriate) (select one or more of the following: “itching,” “irritation,” “redness,” “flaking,” “scaling,”) “associated with.”

(b) The labeling of the product states, under the heading “Uses,” one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) The labeling states “[bullet] [select one of the following: ‘for relief of' or ‘controls'] the symptoms of dandruff [bullet] [select one of the following: ‘additional' or ‘extra'] relief of itching due to dandruff”.

(2) The following terms or phrases may be used in place of or in addition to the words “for the relief of” or “controls” in the indications in paragraph (b)(1) of this section: “fights,” “reduces,” “helps eliminate,” “helps stop,” “controls recurrence of,” “fights recurrence of,” “helps prevent recurrence of,” “reduces recurrence of,” “helps eliminate recurrence of,” “helps stop recurrence of.”

(3) The following terms may be used in place of the words “the symptoms of” in the indication in paragraph (b)(1) of this section: “scalp” (select one or more of the following: “itching,” “irritation,” “redness,” “flaking,” “scaling”) “associated with”.

(1) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should bear a conspicuous warning such as: “Do not use otherwise than as directed.” These drug products must also include the “Keep out of reach of children” warning and the accidental ingestion warning as required in § 330.1(g) of this chapter.

(x) The “Keep out of reach of children” warning and the accidental overdose/ingestion warning set forth in § 330.1(g) of this chapter.

(1) Sodium bicarbonate (or carbonate when used as a component of an effervescent preparation); maximum daily dosage limit 200 mEq. of sodium for persons up to 60 years old and 100 mEq. of sodium for persons 60 years or older, and 200 mEq. of bicarbonate ion for persons up to 60 years old and 100 mEq. of bicarbonate ion for persons 60 years or older. That part of the warning required by § 330.1(g), which states, “Keep this and all drugs out of the reach of children” is not required on a product which contains only sodium bicarbonate powder and which is intended primarily for other than drug uses.

(f) The labeling for antacid drug products containing the active ingredients identified in § 331.11(a), (b), and (d) through (m); permitted combinations of these ingredients provided for in § 331.10; and any of these ingredients or combinations of these ingredients in combination with simethicone (identified in § 332.10 of this chapter and provided for in § 331.15(c)), are exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” With the exception of sodium bicarbonate powder products identified in § 331.11(k)(1), the labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”

(c) The labeling for antiflatulent drug products containing simethicone identified in § 332.10 and antacid/antiflatulent combination drug products provided for in § 332.15, containing the active ingredients identified in § 331.11(a), (b), and (d) through (m) of this chapter are exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” The labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”

(f) The labeling for antitussive drug products containing the active ingredient identified in § 341.14(b)(2) marketed in accordance with § 341.74(d)(2)(iii) is exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” The labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”

(1) “Keep out of reach of children under 6 years of age. [highlighted in bold type] If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.” These warnings shall be used in place of the general warning statements required by § 330.1(g) of this chapter.

(ii) The warning required by § 330.1(g) of this chapter concerning overdose is not required on products containing chlorophyllin copper complex identified in § 357.810(b).

(2) [Reserved]

(f) The terms listed in § 330.1(i) of this chapter 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 OTC drug monograph or by regulation. The terms listed in § 330.1(j) of this chapter may be deleted from the labeling of OTC drug products when the labeling is revised to comply with this section, provided such deletion does not alter the meaning of the labeling that has been established and identified in an applicable OTC drug monograph or by regulation. The terms listed in § 330.1(i) and (j) of this chapter shall not be used to change in any way the specific title, headings, and subheadings required under paragraphs (c)(1) through (c)(9) of this section.

(f) The terms listed in § 330.1(i) of this chapter 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 OTC drug monograph or by regulation. The terms listed in § 330.1(j) of this chapter may be deleted from the labeling of OTC drug products when the labeling is revised to comply with this section, provided such deletion does not alter the meaning of the labeling that has been established and identified in an applicable OTC drug monograph or by regulation. The terms listed in § 330.1(i) and (j) of this chapter shall not be used to change in any way the specific title, headings, and subheadings required under paragraphs (c)(1) through (c)(9) of this section.