Skin protectant drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment.Fed Regist. 2003 Dec 09; 68(236):68509-11.FR
The Food and Drug Administration (FDA) is amending the regulation that established 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. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM).