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Consumer OTC Drugs

Clotrimazole 1% addition to antifungal monograph requested by Schering-Plough.

This article was originally published in The Tan Sheet

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Executive Summary

CLOTRIMAZOLE 1% ADDITION TO ANTIFUNGAL MONOGRAPH REQUESTED by Schering-Plough HealthCare Products in a Nov. 27 citizen petition. The firm is requesting that FDA revise the final monograph for topical antifungal OTC drug products to include clotrimazole 1% for the same indications as other imidazole active ingredients: "the treatment of athlete's foot, jock itch and ringworm and for use in the treatment of superficial skin infections caused by yeast (Candida albicans)." The latter indication is for professional labeling only.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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