Antifungal Drugs
Over-the-counter (OTC) antifungal products are topical medications regulated by the FDA for self-treatment of fungal infections. There's a specific monograph, M005, outlining which ingredients are safe and effective at certain concentrations. These ingredients include clotrimazole, miconazole, tolnaftate, and various undecylenates.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Clioquinol 3 percent | M005.10 (Part 333) |
| Haloprogin 1 percent | M005.10 (Part 333) |
| Miconazole nitrate 2 percent | M005.10 (Part 333) |
| Povidone-iodine 10 percent | M005.10 (Part 333) |
| Tolnaftate 1 percent | M005.10 (Part 333) |
| 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 | M005.10 (Part 333) |
| Clotrimazole 1 percent | M005.10 (Part 333) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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