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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2019]
[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 F--Corn and Callus Remover Drug Products

Sec. 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.

Sec. 358.503 Definitions.

As used in this subpart:

(a) Corn and callus remover drug product. A topical agent used for the removal of corns and calluses.

(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. 358.510 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.

Sec. 358.550 Labeling of corn and callus 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 "corn and callus remover."

(b) Indications. 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."

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

(1) For products containing any ingredient identified in 358.510. (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 or podiatrist."

(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 358.510(a). "Wash affected area and dry thoroughly." (If appropriate: "Cut plaster to fit corn/callus.") "Apply medicated plaster. After 48 hours remove the medicated plaster. Repeat this procedure every 48 hours as needed for up to 14 days (until corn/callus is removed)." (Optional: "May soak corn/callus in warm water for 5 minutes to assist in removal.")

(2) For products containing salicylic acid identified in 358.510(b). "Wash affected area and dry 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 corn/callus. Let dry. Repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)." (Optional: "May soak corn/callus in warm water for 5 minutes to assist in removal.")

(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]

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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