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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2013]
[CITE: 21CFR358]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 358MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
 

Subpart B--Wart Remover Drug Products

Sec. 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.

Sec. 358.103 Definitions.

As used in this subpart:

(a)Wart remover drug product. A topical agent used for the removal of common or plantar warts.

(b)Collodion-like vehicle. 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.

(c)Plaster vehicle. A fabric, plastic, or other suitable backing material in which medication is usually incorporated for topical application to the skin.

Sec. 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.

Sec. 358.150 Labeling of wart remover 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 "wart remover."

(b)Indications. 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."

(c)Warnings. The labeling of the product contains the following warnings under the heading "Warnings":

(1)For products containing any ingredient identified in 358.110. (i) "For external use only."

(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. (i) The labeling should contain an appropriate flammability signal word, e.g. "extremely flammable," "flammable," "combustible," consistent with 16 CFR 1500.3(b)(10).

(ii) "Keep away from fire or flame."

(3)For any product formulated in a volatile vehicle. "Cap bottle tightly and store at room temperature away from heat."

(4)For any product formulated in a collodion-like vehicle. (i) "If product gets into the eye, flush with water for 15 minutes."

(ii) "Avoid inhaling vapors."

(d)Directions. The labeling of the product contains the following information under the heading "Directions":

(1)For products containing salicylic acid identified in 358.110(a). "Wash affected area." (Optional: "May soak wart in warm water for 5 minutes.") "Dry area thoroughly." (If appropriate: "Cut plaster to fit wart.") "Apply medicated plaster. Repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks."

(2)For products containing salicylic acid identified in 358.110(b). "Wash affected area." (Optional: "May soak wart in warm water for 5 minutes.") "Dry area thoroughly. Apply" (select one of the following, as appropriate: "one drop" or "small amount") "at a time with" (select one of the following, as appropriate: "applicator" or "brush") "to sufficiently cover each wart. Let dry. Repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks."

(3)For products containing salicylic acid identified in 358.110(c). "Wash affected area." (Optional: "May soak wart in warm water for 5 minutes.") "Dry area thoroughly. Gently smooth wart surface with emery file supplied." (If appropriate: "Cut plaster to fit wart.") "Apply a drop of warm water to the wart, keeping the surrounding skin dry. Apply medicated plaster at bedtime and leave in place for at least 8 hours. In the morning, remove plaster and discard. Repeat procedure every 24 hours as needed (until wart is removed) for up to 12 weeks."

(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]

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 55 FR 33255, Aug. 14, 1990, unless otherwise noted.

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