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Astringent direct final rule

This article was originally published in The Tan Sheet

Executive Summary

FDA will allow small package labeling provisions for aluminum sulfate marketed as a styptic pencil due to "extremely low risk" in consumer use situations; modifications are based on those for OTC lip protectant/lip balm drug products, according to Skin Protectant Astringents 1direct final rule. Published in June 13 Federal Register, rule will revise labeling for active ingredient aluminum acetate to be in line with shorter versions allowed for colloidal oatmeal, sodium bicarbonate. FDA published direct final rule along with 2proposed version; both invite public input by Aug. 25. If no opposing comments are received, FDA will publish a confirmation notice that final rule will become effective in 135 days. Astringents are covered under Skin Protectant Final Monograph published June 4 (3"The Tan Sheet" June 9, 2003, p. 6)...

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Astringent regulation

Final rule revising astringent drug products labeling, making small packaging exemptions consistent with OTC skin protectant drug products final rule became effective Oct. 27. The direct final rule amends regulation by establishing conditions under which OTC skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. FDA published rule in June 13 Federal Register (1"The Tan Sheet" June 16, 2003, p. 10)...

Skin Protectant Final Rule Allows Cross-Monograph Ingredient Combinations

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