설명(영) |
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Antifungal Agents are active ingredients used in topical antifungal drug products. In the U.S., in 21CFR333.203, an antifungal agent is defined as "a drug which inhibits the growth and reproduction of fungal cells and decreases the number of fungi present." See 21CFR333.210 for a listing of the active drug ingredients.
In the EU and other countries, antifungal products are considered to be cosmetics, and are controlled under cosmetic regulations which may not require pre-clearance or pre-market approval of active ingredients. In Japan, antifungal agents may be regarded as drugs subject to pre-approval requirements.
The listing below includes those ingredients reported to be safe and effective for use in U.S. over-the-counter (OTC) drug products, as well as those identified by suppliers as antifungal agents. These ingredients may also have a cosmetic purpose in cosmetic formulations.
To identify the currently allowed antifungal agents, or for information on ingredient use limitations, etc., the reader is directed to contact the U.S. Food and Drug Administration for the most recent information concerning this drug category.
The U.S. approved drug ingredients are identified below with a star prefix. Whenever the U.S. drug name differs from the INCI name, the U.S. drug name is presented parenthetically. |