Skin Protectant Rule Amended To Include Prevention, Chafing Indications
This article was originally published in The Rose Sheet
Executive Summary
FDA will permit optional labeling language for OTC skin protectant drug products to include the indications "helps prevent" and "chafed" under a technical amendment to the final monograph, published in the Federal Register Dec. 9
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FDA denies Cosmetic, Toiletry and Fragrance Association request to stay enforcement action on OTC skin protectant final monograph in a Feb. 24 letter to the association. Request to stay action is "moot" after FDA granted CTFA's citizen petition request to include the indications "help prevent" and "chafing" in monograph in a technical amendment published Dec. 9 in the Federal Register (1"The Rose Sheet" Dec. 15, 2003, p. 10). Compliance dates for OTC skin protectant drug products are June 6, 2005 for products with annual sales less than $25,000 and June 4, 2004 for all others. FDA released the rule June 4 (2"The Rose Sheet" June 9, 2003, p. 3)...
OTC skin protectants
FDA denies Cosmetic, Toiletry and Fragrance Association request to stay enforcement action on OTC skin protectant final monograph in a Feb. 24 letter to the association. Request to stay action is "moot" after FDA granted CTFA's citizen petition request to include the indications "help prevent" and "chafing" in monograph in a technical amendment published Dec. 9 in the Federal Register (1"The Rose Sheet" Dec. 15, 2003, p. 10). Compliance dates for OTC skin protectant drug products are June 6, 2005 for products with annual sales less than $25,000 and June 4, 2004 for all others. FDA released the rule June 4 (2"The Rose Sheet" June 9, 2003, p. 3)...
Skin Protectant Chafing Indications Should Be Included In Final Rule - CTFA
The OTC Skin Protectant Drug Products Final Monograph should include indications for chafing based on conclusions made by FDA in the tentative final monograph, according to the Cosmetic, Toiletry and Fragrance Association