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Acne Active Ingredient Combination Urged In Citizen Petition To FDA

This article was originally published in The Rose Sheet

Executive Summary

FDA should permit the use of 2% salicylic acid and 10% sulfur as combination active ingredients in the final monograph for topical acne drug products, D'Arcy Revolutionary Skincare states in a 1citizen petition to FDA

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FDA denies acne petition

D'Arcy Skincare petition requesting 10% sulfur and 2% salicylic acid combination be recognized as safe and effective under the OTC topical acne drug products monograph is denied by FDA. Agency says it is "unaware of any clinical studies demonstrating that both sulfur and salicylic acid contribute to the overall effectiveness of the combination" and notes D'Arcy did not submit effectiveness data to support its position. Although 3%-10% sulfur and .5%-2% salicylic acid are permitted under the monograph, they are not allowed at those levels in combination. D'Arcy includes 2% salicylic acid and 10% sulfur in combination in its Drying Lotion acne treatment and argued it has seen no adverse effects during more than 20 years of marketing the product. The company also submitted repeat insult patch test to FDA to support safety and consumer testimonials to prove efficacy (1"The Rose Sheet" July 19, 2004, p. 8)...

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