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Zdrowie i gospodarka · 04/06/2003

FDA Issues Final Monograph for Over-the-Counter Skin Protectant Drug Products

The US Food and Drug Administration (FDA) has published a final rule establishing conditions for the safe and effective use of over-the-counter (OTC) skin protectant drug products, including those for minor cuts, scrapes, and burns, as well as poison ivy, oak, and sumac, and insect bites. This final rule amends the existing regulation to include new active ingredients and lifts a stay on amendments to the final monograph for OTC sunscreen products.

Source: Federal Register — Food and Drug AdministrationOpen original release →