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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 2018.

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, 2018]
[CITE: 21CFR333.210]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 333 -- TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart C--Topical Antifungal Drug Products

Sec. 333.210 Antifungal active ingredients.

The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient:

(a) Clioquinol 3 percent.

(b) Haloprogin 1 percent.

(c) Miconazole nitrate 2 percent.

(d) Povidone-iodine 10 percent.

(e) Tolnaftate 1 percent.

(f) undecylenic acid , calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent.

(g) Clotrimazole 1 percent.

[58 FR 49898, Sept. 23, 1993, as amended at 67 FR 5943, Feb. 8, 2002]

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