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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 333 - Topical Antimicrobial Drug Products for over-the-Counter Human Use |
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Subpart C - Topical Antifungal Drug Products |
§ 333.210 - Antifungal active ingredients.
Latest version.
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§ 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]