PART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 55 FR 33255, Aug. 14, 1990, unless otherwise noted. Subpart A [Reserved] Subpart B—Wart Remover Drug Products § 358.101 Scope. (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. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 358.103 Definitions. As used in this subpart: (a) Wart remover drug product. (b) Collodion-like vehicle. (c) Plaster vehicle. § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each ingredient. (a) Salicylic acid 12 to 40 percent in a plaster vehicle. (b) Salicylic acid 5 to 17 percent in a collodion-like vehicle. (c) Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle. § 358.150 Labeling of wart remover drug products. (a) Statement of identity. (b) Indications. (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.” (c) Warnings. (1) For products containing any ingredient identified in § 358.110. (ii) “Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation.” (iii) “If discomfort persists, see your doctor.” (iv) “Do not use on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.” (2) For any product formulated in a flammable vehicle. (ii) “Keep away from fire or flame.” (3) For any product formulated in a volatile vehicle. (4) For any product formulated in a collodion-like vehicle. (ii) “Avoid inhaling vapors.” (d) Directions. (1) For products containing salicylic acid identified in § 358.110(a). (2) For products containing salicylic acid identified in § 358.110(b). (3) For products containing salicylic acid identified in § 358.110(c). (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. (f) The phrase “or podiatrist” may be used in addition to the word “doctor” in any of the labeling statements in this section when a product is labeled with the indication identified in § 358.150(b)(2). [55 FR 33255, Aug. 14, 1990; 55 FR 37403, Sept. 11, 1990, as amended at 57 FR 44495, Sept. 28, 1992; 59 FR 60317, Nov. 23, 1994] Subpart C [Reserved] Subpart D—Ingrown Toenail Relief Drug Products Source: 68 FR 24348, May 7, 2003, unless otherwise noted. § 358.301 Scope. (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. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter 1 of title 21 unless otherwise noted. § 358.303 Definitions. As used in this subpart: (a) Ingrown toenail relief drug product. (b) Retainer ring. § 358.310 Ingrown toenail relief active ingredient. The active ingredient of the product is sodium sulfide 1 percent in a gel vehicle. The gel vehicle is an aqueous, semisolid system with large organic molecules interpenetrated with a liquid. § 358.350 Labeling of ingrown toenail relief drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter. (2) “Do not use [bullet] 1 1 (3) “Ask a doctor before use if you have [bullet] diabetes [bullet] poor circulation [bullet] gout”. (4) “When using this product [bullet] use with a retainer ring”. (5) “Stop use and ask a doctor if [bullet] redness or swelling of your toe increases [bullet] discharge is present around the nail [bullet] symptoms last more than 7 days or clear up and occur again within a few days”. (d) Directions. (1) “[Bullet] adults and children 12 years and over:” (i) “[Bullet] wash the affected area and dry thoroughly [bullet] place retainer ring on toe with slot over the area where the ingrown nail and the skin meet. Smooth ring down firmly. [bullet] apply enough gel product to fill the slot in the ring [bullet] place round center section of bandage strip directly over the gel-filled ring to seal the gel in place. Smooth ends of bandage strip around toes.” (ii) “[Bullet] repeat twice daily (morning and night) for up to 7 days until discomfort is relieved or until the nail can be lifted out of the nail groove and easily trimmed”. (2) “[Bullet] children under 12 years: ask a doctor”. Subpart E [Reserved] Subpart F—Corn and Callus Remover Drug Products Source: 55 FR 33261, Aug. 14, 1990, unless otherwise noted. § 358.501 Scope. (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. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 358.503 Definitions. As used in this subpart: (a) Corn and callus remover drug product. (b) Collodion-like vehicle. (c) Plaster vehicle. § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the dosage form established for each ingredient. (a) Salicylic acid 12 to 40 percent in a plaster vehicle. (b) Salicylic acid 12 to 17.6 percent in a collodion-like vehicle. § 358.550 Labeling of corn and callus remover drug products. (a) Statement of identity. (b) Indications. (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.” (c) Warnings. (1) For products containing any ingredient identified in § 358.510. (ii) “Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation.” (iii) “If discomfort persists, see your doctor or podiatrist.” (2) For any product formulated in a flammable vehicle. (ii) “Keep away from fire or flame.” (3) For any product formulated in a volatile vehicle. (4) For any product formulated in a collodion-like vehicle. (ii) “Avoid inhaling vapors.” (d) Directions. (1) For products containing salicylic acid identified in § 358.510(a). (2) For products containing salicylic acid identified in § 358.510(b). (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. [55 FR 33261, Aug. 14, 1990, as amended at 57 FR 44494, Sept. 28, 1992] Subpart G—Pediculicide Drug Products Source: 58 FR 65455, Dec. 14, 1993, unless otherwise noted. § 358.601 Scope. (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. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 358.603 Definition. As used in this subpart: Pediculicide drug product. § 358.610 Pediculicide active ingredients. The active ingredients of the product consist of the combination of pyrethrum extract (providing a concentration of pyrethrins of 0.17 to 0.33 percent) with piperonyl butoxide (2 to 4 percent) in a nonaerosol dosage formulation. [63 FR 43303, Aug. 13, 1998] § 358.650 Labeling of pediculicide drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter. (2) “Do not use [bullet] 1 1 (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. (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 (ii) For nonshampoo products (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. (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”. [68 FR 75417, Dec. 31, 2003] Subpart H—Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis Source: 56 FR 63568, Dec. 4, 1991, unless otherwise noted. § 358.701 Scope. (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. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 358.703 Definitions. As used in this subpart: (a) Coal tar. (b) Dandruff. (c) Psoriasis. (d) Seborrheic dermatitis. (e) Selenium sulfide, micronized. Selenium sulfide that has been finely ground and that has a median particle size of approximately 5 micrometers (µm), with not more than 0.1 percent of the particles greater than 15 µm and not more than 0.1 percent of the particles less than 0.5 µm. [56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994] § 358.710 Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis. The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient: (a) Active ingredients for the control of dandruff. (2) Pyrithione zinc, 0.3 to 2 percent when formulated to be applied and then washed off after brief exposure. (3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp. (4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (6) Selenium sulfide, micronized, 0.6 percent. (7) Sulfur, 2 to 5 percent. (b) Active ingredients for the control of seborrheic dermatitis. (2) Pyrithione zinc, 0.95 to 2 percent when formulated to be applied and then washed off after brief exposure. (3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp. (4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (c) Active ingredients for the control of psoriasis. (2) Salicylic acid, 1.8 to 3 percent. [56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994] § 358.720 Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of dandruff. (b) Combination of control of dandruff and external analgesic active ingredients. [72 FR 9852, Mar. 6, 2007] § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. (1) “Dandruff (insert product form)” or “antidandruff (insert product form)”. (2) “Seborrheic dermatitis (insert product form)”. (3) “Psoriasis (insert product form)”. (b) Indications. (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.” (c) Warnings. (1) For products containing any ingredient identified in § 358.710. (ii) “Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.” (iii) “If condition worsens or does not improve after regular use of this product as directed, consult a doctor.” (2) For any product containing coal tar identified in § 358.710(a), (b), or (c). (ii) “Do not use for prolonged periods without consulting a doctor.” (3) For products containing coal tar when formulated to be applied and left on the skin (e.g., creams, ointments, lotions). (4) For products containing coal tar identified in § 358.710(c) for the control of psoriasis. (5) For products containing any ingredient identified in § 358.710(b) or (c) for the control of seborrheic dermatitis or psoriasis. (d) Directions. (1) For products containing active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis when formulated to be applied and then washed off after brief (a few minutes) exposure (e.g, shampoos, preshampoo rinses, postshampoo rinses). (2) For products containing active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis when formulated so as to be applied and left on the skin or scalp (e.g., creams, ointments, lotions, hairgrooms). (3) For products containing active ingredients for the control of seborrheic dermatitis or psoriasis of the skin when formulated as soaps. (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. § 358.760 Labeling of permitted combinations of active ingredients for the control of dandruff. The statement of identity, indications, warnings, and directions for use, respectively, 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. (a) Statement of identity. (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). (2) [Reserved] (b) Indications. (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). (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”. (c) Warnings. (d) Directions. (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). (2) [Reserved] [72 FR 9852, Mar. 6, 2007]