GroundRules
21 CFR 333.210: Antifungal active ingredients.
Where this section sits in the code
- 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
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON