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Astringent Final Rule Contains Revised Labeling, Small Package Exemptions

This article was originally published in The Rose Sheet

Executive Summary

The Skin Protectant Astringent direct final rule includes minor labeling changes and small packaging exemptions to bring the astringent portion of the Skin Protectant Monograph in line with the rest of the rule, FDA says. The agency published the direct final rule in the Federal Register June 13

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Astringent rule

Effective date for direct final rule for astringents marketed under the OTC Skin Protectant Monograph is June 13, 2004, FDA says in a Jan. 22 Federal Register notice correcting an earlier published effective date of Oct. 27, 2003. FDA published an amended final rule for skin protectant astringent drug products in June and included small packaging exemptions and minor labeling changes along with the incorrect effective date (1"The Rose Sheet" June 16, 2003, p. 10)...

Astringent rule

Effective date for direct final rule for astringents marketed under the OTC Skin Protectant Monograph is June 13, 2004, FDA says in a Jan. 22 Federal Register notice correcting an earlier published effective date of Oct. 27, 2003. FDA published an amended final rule for skin protectant astringent drug products in June and included small packaging exemptions and minor labeling changes along with the incorrect effective date (1"The Rose Sheet" June 16, 2003, p. 10)...

Skin Protectant Final Rule Allows Cross-Monograph Ingredient Combinations

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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