Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment

The Food and Drug Administration (FDA) published a document in the Federal Register of June 4, 2003 (68 FR 33362), that established a final monograph with conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. That final monograph included OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. That document also amended the regulation that lists nonmonograph active ingredients by adding those OTC skin protectant ingredients that were found to be not generally recognized as safe and effective. However, that document had an incorrect "approved as of" date (May 7, 1991, instead of November 10, 1993) in Sec. 310.545(a)(18)(v)(A) and (a)(18)(vi)(A) in part 310 (21 CFR part 310) and incorrectly added paragraphs (a)(18)(ii) through (a)(18)(vi)(A) to Sec. 310.545(d)(1) when those paragraphs should have been included in Sec. 310.545(d)(11). This document corrects those errors.