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OTC dandruff products

This article was originally published in The Rose Sheet

Executive Summary

AAC Consulting Group asks FDA in a Feb. 22 letter to clarify whether shampoos containing zinc pyrithione, a Category I ingredient, must be labeled as OTCs rather than cosmetics. AAC claims that products currently marketed as cosmetics contain monograph levels of zinc pyrithione and lack appropriate identity statements, warnings, directions for use and indications. A second Feb. 22 letter from AAC asks the agency whether menthol, which is considered nonmonograph for all uses, could be used as an inactive ingredient in OTC dandruff products. Referring to an April 1977 proposal on inactive ingredients that was never made final, AAC requested guidance on what a product manufacturer must do to establish that an ingredient fulfills the requirements for use as an inactive product ingredient
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