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Selenium sulfide for dandruff

Executive Summary

FDA turns down Ross Laboratories' request that micronized selenium sulfide at 0.6% concentration be included in the final monograph for dandruff and seborrheic dermatitis as a Category I ingredient for dandruff control. FDA said only two out of five studies submitted by Ross "could be regarded as well-controlled clinical trials" and that only one study showed the ingredient more effective than shampoo base. "At least one additional well-controlled study of adequate sample size" is needed to support the efficacy of 0.6% micronized selenium sulfide, FDA stated.

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