Comparative ability of various prescription and over-the-counter topical antifungal drug products to inhibit the growth of C. albicans.
On September 23, 1993, the Food and Drug Administration (FDA) published the final monograph and rule for topical antifungal drug products. This monograph specifies the ingredients, concentration, and labeling under which over-the-counter (OTC) topical antifungal drug products may be marketed without further FDA approval. Currently, the nine products tested are labeled as antifungal because of their ability to inhibit the growth of yeast (C. albicans) in vitro. Over-the-counter products containing 2% miconazole nitrate--an ingredient and concentration identified as safe and effective--were found to inhibit the growth of C. albicans as effectively as mycostatin cream. Two percent miconazole nitrate was also inhibitory to C. albicans at greater dilutions than five other antifungal products containing chloroxylenol and clotri mazole. Chloroxylenol and clotrimazole are nonmonographed ingredients.
Miner
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N
Armstrong
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M
D000287:Administration, Topical; D000935:Antifungal Agents / Q000494:pharmacology*; D002176:Candida albicans / Q000187:drug effects* / Q000254:growth & development; D004353:Drug Evaluation, Preclinical; D011307:Drug Prescriptions; D006801:Humans; D004366:Nonprescription Drugs / Q000494:pharmacology
D000935:Antifungal Agents; D004366:Nonprescription Drugs