Skin Protectant Drug Products for Over-the-Counter Human Use, Astringent Drug Products; Final Monograph, Direct Final Rule; and Confirmation of Effective Date; Corrections

The Food and Drug Administration (FDA) is correcting a document that published in the Federal Register of June 13, 2003 (68 FR 35290), that amended the regulation that established conditions under which over-the-counter (OTC) skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. This action revised some labeling for astringent drug products to be consistent with the final rule for OTC skin protectant drug products that published June 4, 2003 (68 FR 33362), and added labeling for certain small packages (styptic pencils). FDA is also correcting a document that confirmed the effective date of the direct final rule that published on October 9, 2003 (68 FR 58273). These documents were published with an incorrect effective date and an incorrect confirmation of effective date, respectively. This document corrects those errors.