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Skin Protectant Final Rule Allows Cross-Monograph Ingredient Combinations

This article was originally published in The Rose Sheet

Executive Summary

The Skin Protectant Final Monograph covering products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac and insect bites allows for certain cross-monograph ingredient combinations, according to the rule published in the 1Federal Register June 4

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FDA Clarifies Skin Protectant Labeling, Ingredient Combination Options

FDA endeavors to clarify the active ingredients manufacturers may combine in OTC skin protectant drug products and corresponding label requirements in draft guidance released Aug. 1

FDA Clarifies Skin Protectant Labeling, Ingredient Combination Options

FDA endeavors to clarify the active ingredients manufacturers may combine in OTC skin protectant drug products and corresponding label requirements in draft guidance released Aug. 1

FDA guides industry in labeling skin protectants

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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