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Final Monograph on Skin Protectant Drug Products

06/04/2003
Federal Register Final rule: FDA is issuing a final rule in the form of a final monograph establishing conditions under which OTC skin protectant drug products are generally recognized as safe and effective and not misbranded as part of the ongoing review of OTC drug products conducted by FDA. The final monograph includes OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. To view this final rule, click here.

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