---
kind: "section"
citation: "21 C.F.R. § 358.650"
title: "21"
number: "358.650"
heading: "Labeling of pediculicide drug products."
url: "https://uscodex.org/cfr/21/358.650"
---

# §358.650. Labeling of pediculicide drug products.

- (a) **Statement of identity.** The labeling of the product contains the established name of the drug, if any, and identifies the product as a “lice treatment.”
- (b) **Indications.** 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)](#b), may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2) of this chapter, subject to the provisions of [section 502](/cfr/21/502.md) of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=a) of the act.
- (c) **Warnings.** The labeling of the product contains the following warnings under the heading “Warnings”:
  - (1) “For external use only” in accord with [§ 201.66(c)(5)(i)](/cfr/21/201.66.md?p=c-5-i) of this chapter.
  - (2) “Do not use [bullet] 1 near eyes [bullet] inside nose, mouth, or vagina [bullet] on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.”
  - (3) “Ask a doctor before use if you are [bullet] allergic to ragweed. May cause breathing difficulty or an asthmatic attack.”
  - (4) “When using this product [bullet] keep eyes tightly closed and protect eyes with a washcloth or towel [bullet] if product gets in eyes, flush with water right away [bullet] scalp itching or redness may occur”.
  - (5) “Stop use and ask a doctor if [bullet] breathing difficulty occurs [bullet] eye irritation occurs [bullet] skin or scalp irritation continues or infection occurs”.
- (d) **Directions.** The labeling of the product contains the following information under the heading “Directions”:
  - (1) **The labeling states “[bullet] Important—** Read warnings before use” [statement shall appear first and in bold type].
  - (2) **The labeling states “adults and children 2 years and over—** ” [in bold type].
  - (3) For head lice treatment products “Inspect [in bold type] [bullet] check each household member with a magnifying glass in bright light for lice/nits (eggs) [bullet] look for tiny nits near scalp, beginning at back of neck and behind ears [bullet] examine small sections of hair at a time [bullet] unlike dandruff which moves when touched, nits stick to the hair [bullet] if either lice or nits are found, treat with this product”.
  - (4) **Select one of the following—**
    - (i) **For shampoo products—** “Treat [in bold type] [bullet] apply thoroughly to (optional, may add “dry”) hair or other affected area. For head lice, first apply behind ears and to back of neck. [bullet] allow product to remain for 10 minutes, but no longer [bullet] use warm water to form a lather, shampoo, then thoroughly rinse [bullet] for head lice, towel dry hair and comb out tangles”.
    - (ii) **For nonshampoo products—** “Treat [in bold type] [bullet] apply thoroughly to (optional, may add “dry”) hair or other affected area. For head lice, first apply behind ears and to back of neck. [bullet] allow product to remain for 10 minutes, but no longer [bullet] wash area thoroughly with warm water and soap or shampoo [bullet] for head lice, towel dry hair and comb out tangles”.
  - (5) “Remove lice and their eggs (nits) [in bold type] [bullet] use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove). [bullet] hair should remain slightly damp while removing nits [bullet] if hair dries during combing, dampen slightly with water [bullet] for head lice, part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours. [bullet] lift a 1- to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp. [bullet] pin back each strand of hair after combing [bullet] clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back. [bullet] after combing, thoroughly recheck for lice/nits. Repeat combing if necessary. [bullet] check daily for any lice/nits that you missed”.
  - (6) The labeling states “[bullet] a second treatment must be done in 7 to 10 days to kill any newly hatched lice”.
  - (7) **The labeling states “[bullet] if infestation continues, see a doctor for other treatments”.**
  - (8) **The labeling states “children under 2 years—** ” [in bold type] “ask a doctor”.
- (e) **Other information.** The labeling of the product contains the following statements, as appropriate, under the heading “Other information.” This information may appear in a package insert. If a package insert is used, the “Other information” section on the outer carton or container label shall include a statement referring to the package insert for additional information.
  - (1) “Head lice [highlighted in bold type] [bullet] lay small white eggs (nits) on hair shaft close to scalp [bullet] nits are most easily found on back of neck or behind ears [bullet] disinfect hats, hair ribbons, scarves, coats, towels, and bed linens by machine washing in hot water (above 54 °C (130 °F)), then using hottest dryer cycle for at least 20 minutes [bullet] items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again [bullet] items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose [bullet] soak all combs and brushes in hot water (above 54 °C (130 °F)) for at least 10 minutes [bullet] vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people”.
  - (2) “Pubic (crab) lice [highlighted in bold type] [bullet] may be transmitted by sexual contact. Sexual partners should be treated simultaneously to avoid reinfestation [bullet] lice are very small and look like brown or grey dots on skin [bullet] usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface [bullet] may be present on the short hairs of groin, thighs, trunk, and underarms, and occasionally on the beard and mustache [bullet] disinfect underwear by machine washing in hot water (above 54 °C (130 °F)), then using hottest dryer cycle for at least 20 minutes”.
  - (3) “Body lice [highlighted in bold type] [bullet] body lice and their eggs (nits) are generally found in the seams of clothing particularly in waistline and armpit area [bullet] body lice feed on skin then return to clothing to lay their eggs [bullet] disinfect clothing by machine washing in hot water (above 54 °C (130 °F)), then using hottest dryer cycle for at least 20 minutes [bullet] do not seal clothing in a plastic bag because nits can remain dormant for up to 30 days”.

## Notes

### Amendments

[68 FR 75417, Dec. 31, 2003]

### Source

Source: 58 FR 65455, Dec. 14, 1993, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 55 FR 33255, Aug. 14, 1990, unless otherwise noted.

### Amendments

[68 FR 75417, Dec. 31, 2003]