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Consumer OTC Drugs

ALOE VERA ROLE IN WINNING SOLUTIONS' ATHLETE'S FOOT PRODUCT

This article was originally published in The Tan Sheet

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Executive Summary

ALOE VERA ROLE IN WINNING SOLUTIONS' ATHLETE'S FOOT PRODUCT is the "most important issue to be resolved" before the company begins a low-dose tolnaftate clinical study, FDA told Winning Solutions in a May 20 letter. Responding to a citizen's petition submitted by the company in January to support the use of a lower concentration of tolnaftate for athlete's foot (tinea pedis) than the 1% allowed in the September 1993 OTC topical antifungals final monograph, the agency noted that Winning Solutions has to first determine whether the 60% aloe vera base of its product serves as an inactive vehicle or an adjuvant in the formulation.

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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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