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United States • Title 21 CFR • Part 358
This part of the CFR outlines the requirements for miscellaneous external drug products for over-the-counter human use, specifically focusing on wart removers, ingrown toenail relief products, corn and callus removers, and pediculicides. It details the scope, definitions, active ingredients, and labeling requirements for these products to be considered generally recognized as safe and effective (GRASE) and not misbranded.
(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.
As used in this subpart: Wart remover drug product.(a) A topical agent used for the removal of common or plantar warts. Collodion-like vehicle.(b) A solution containing pyroxylin (nitrocellulose) in an appropriate nonaqueous solvent that leaves a transparent cohesive film when applied to the skin in a thin layer. Plaster vehicle.(c) A fabric, plastic, or other suitable backing material in which medication is usually incorporated for topical application to the skin.
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.
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “wart remover.” Indications.(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.” Warnings.(c) The labeling of…
(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.
As used in this subpart: Ingrown toenail relief drug product.(a) A drug product applied to an ingrown toenail that relieves pain or discomfort either by softening the nail or by hardening the nail bed. Retainer ring.(b) A die cut polyethylene foam pad coated on one side with medical grade acrylic pressure-sensitive adhesive. The retainer ring has slots, center-cut completely through the foam with the cut of sufficient size to allow for localization of an active ingredient in a gel vehicle to a specific target area. The retainer ring is used with adhesive bandage strips to place over the retainer ring to hold it in place.
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.
Statement of identity.(a) The labeling of the product contains the established name of the product, if any, and identifies the product as an “ingrown toenail relief product” or as an “ingrown toenail discomfort reliever.” Indications.(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. Warnings.(c) 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) of this chapter. 1(2) “Do not use [bullet] on open sores”. (3) “Ask a doctor before use if you…
(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.
As used in this subpart: Corn and callus remover drug product.(a) A topical agent used for the removal of corns and calluses. Collodion-like vehicle.(b) A solution containing pyroxylin (nitrocellulose) in an appropriate nonaqueous solvent that leaves a transparent cohesive film when applied to the skin in a thin layer. Plaster vehicle.(c) A fabric, plastic, or other suitable backing material in which medication is usually incorporated for topical application to the skin.
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.
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “corn and callus remover.” Indications.(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.” Warnings.(c) The labeling of the product…
(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.
As used in this subpart: Pediculicide drug product. A drug product for the treatment of head, pubic (crab), and body lice.
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]
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “lice treatment.” Indications.(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. Warnings.(c) 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) of this chapter. 1(2) “Do not use [bullet] 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…
(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.
As used in this subpart: Coal tar.(a) The tar used for medicinal purposes that is obtained as a byproduct during the destructive distillation of bituminous coal at temperatures in the range of 900 °C to 1,100 °C. It may be further processed using either extraction with alcohol and suitable dispersing agents and maceration times or fractional distillation with or without the use of suitable organic solvents. Dandruff.(b) A condition involving an increased rate of shedding of dead epidermal cells of the scalp. Psoriasis.(c) A condition of the scalp or body characterized by irritation, itching, redness, and extreme excess shedding of dead epidermal cells. Seborrheic dermatitis.(d) A condition of the scalp or body characterized by irritation, itching, redness, and excess shedding of dead epidermal cells. (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]
The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient: Active ingredients for the control of dandruff.(a) (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product. (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. Active ingredients for the control of seborrheic dermatitis.(b) (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product. (2) Pyrithione zinc, 0.95 to…
Combination of active ingredients for the control of dandruff.(a) Salicylic acid identified in § 358.710(a)(4) may be combined with sulfur identified in § 358.710(a)(7) provided each ingredient is present within the established concentration and the product is labeled according to § 358.750. Combination of control of dandruff and external analgesic active ingredients.(b) Coal tar identified in § 358.710(a)(1) may be used at a concentration of 1.8 percent coal tar solution, on a weight to volume basis, in combination with menthol, 1.5 percent, in a shampoo formulation provided the product is labeled according to § 358.760. [72 FR 9852, Mar. 6, 2007]
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product with one or more of the following, as appropriate: (1) “Dandruff (insert product form)” or “antidandruff (insert product form)”. (2) “Seborrheic dermatitis (insert product form)”. (3) “Psoriasis (insert product form)”. Indications.(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…
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. Statement of identity.(a) For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b).(1) The label states “dandruff/anti-itch shampoo” or “antidandruff/anti-itch shampoo”. (2) [Reserved] Indications.(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…
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