[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR358.650] [Page 297-298] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents Subpart G--Pediculicide Drug Products Sec. 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 ``pediculicide (lice treatment)'' or ``lice treatment.'' (b) Indications. The labeling of the product states, under the heading ``Indications,'' the following: ``For the treatment of head, pubic (crab), and body lice.'' 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 Sec. 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. (c) Warnings. The labeling of the product contains the following warnings under the heading ``Warnings'': (1) ``Use with caution on persons allergic to ragweed.'' (2) ``For external use only. Do not use near the eyes or permit contact with mucous membranes, such as inside the nose, mouth, or vagina, as irritation may occur. Keep out of eyes when rinsing hair. Adults and children: Close eyes tightly and do not open eyes until product is rinsed out. Also, protect children's eyes with washcloth, towel or other suitable material, or by a similar method. If product gets into the eyes, immediately flush with water.'' (3) ``If skin irritation or infection is present or develops, discontinue use and consult a doctor. Consult a doctor if infestation of eyebrows or eyelashes occurs.'' (4) The word ``physician'' may be substituted for the word ``doctor'' in any of the warning statements in this paragraph. (d) Directions. The labeling of the product contains the following information under the heading ``Directions'': (1) For all products. ``Important: Read warnings before using.'' [statement in boldface type] (2) For nonshampoo products. ``Apply to affected area until all the hair is thoroughly wet with product. Allow product to remain on area for 10 minutes but no longer. Wash area thoroughly with warm water and soap or shampoo. A fine-toothed comb or a special lice/nit removing comb may be used to help remove dead lice or their eggs (nits) from hair. A second treatment must be done in 7 to 10 days to kill any newly hatched lice.'' (3) For products formulated for use as a shampoo. ``Apply to affected area until all the hair is thoroughly wet with product. Allow product to remain on area for 10 minutes but no longer. Add sufficient warm water to form a lather and shampoo as usual. Rinse thoroughly. A fine-toothed comb or a special lice/nit removing comb may be used to help remove dead lice or their eggs (nits) from hair. A second treatment must be done in 7 to 10 days to kill any newly hatched lice.'' [[Page 298]] (e) Other required statements. (1) ``Head Lice: Head lice live on the scalp and lay small white eggs (nits) on the hair shaft close to the scalp. The nits are most easily found on the nape of the neck or behind the ears. All personal headgear, scarfs, coats, and bed linen should be disinfected by machine washing in hot water and drying, using the hot cycle of a dryer for at least 20 minutes. Personal articles of clothing or bedding that cannot be washed may be dry-cleaned, sealed in a plastic bag for a period of about 2 weeks, or sprayed with a product specifically designed for this purpose. Personal combs and brushes may be disinfected by soaking in hot water (above 130 deg.F) for 5 to 10 minutes. Thorough vacuuming of rooms inhabited by infected patients is recommended.'' (2) ``Pubic (Crab) Lice: Pubic lice may be transmitted by sexual contact; therefore, sexual partners should be treated simultaneously to avoid reinfestation. The lice are very small and look almost like brown or grey dots on the skin. Pubic lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface. In hairy individuals, pubic lice may be present on the short hairs of the thighs and trunk, underarms, and occasionally on the beard and mustache. Underwear should be disinfected by machine washing in hot water; then drying, using the hot cycle for at least 20 minutes.'' (3) ``Body Lice: Body lice and their eggs are generally found in the seams of clothing, particularly in the waistline and armpit area. They move to the skin to feed, then return to the seams of the clothing where they lay their eggs. Clothing worn and not laundered before treatment should be disinfected by the same procedure as described for head lice, except that sealing clothing in a plastic bag is not recommended for body lice because the nits (eggs) from these lice can remain dormant for a period of up to 30 days.'' [58 FR 65455, Dec. 14, 1993, as amended at 64 FR 13296, Mar. 17, 1999]