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

This article was originally published in The Tan Sheet

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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