Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) ophthalmic drug products are generally recognized as safe and effective and not misbranded. This amendment clarifies the active ingredient in OTC eyewash drug products and the labeling of the active ingredient and its purpose. This final rule is part of FDA's ongoing review of OTC drug products.
D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D004366:Nonprescription Drugs; D009883:Ophthalmic Solutions; D014481:United States; D014486:United States Food and Drug Administration; D014867:Water
D004366:Nonprescription Drugs; D009883:Ophthalmic Solutions; D014867:Water