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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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