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FDA guides industry in labeling skin protectants

This article was originally published in The Rose Sheet

Executive Summary

Over-the-counter skin protectant drug products - intended to "temporarily protect injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and [which] may help provide relief" - can be made with combinations of skin protectant active ingredients as well as combinations of skin protectant substances and active ingredients from other OTC drug monographs, such as external analgesics, first-aid antiseptics or sunscreens, FDA explains in Aug. 1 notice. "Each of these combinations has specific labeling requirements, and therefore labeling of OTC skin protectant drug products in complex," the agency says. Guidance is designed to clarify permitted ingredient combinations and outline appropriate indications, warnings and directions for particular products and formulations. Final monograph for skin protectants was published in June 2003 (1"The Rose Sheet" June 9, 2003, p. 3)...
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