Zdrowie i gospodarka · 17.02.1995

Topical Drug Products Containing Benzoyl Peroxide; Required Labeling

The Food and Drug Administration (FDA) is proposing additional labeling (warning and directions) for all topically-applied acne treatment drug products containing benzoyl peroxide. The warning advises consumers to avoid unnecessary sun exposure and to use a sunscreen when using a benzoyl peroxide product to treat acne. The directions provide information about applying benzoyl peroxide and a sunscreen, and about discontinuing use of both products if irritation or sensitivity develops. Prescription drug products will need a patient package insert to convey this information to product users. The agency is requesting public comment on whether a consumer package insert should be required to provide additional information FDA believes users of these benzoyl peroxide products should have. That information would summarize some problems that occurred when benzoyl peroxide was used in tests on mice and would mention that additional studies are currently being conducted. The final status of benzoyl peroxide in over-the- counter (OTC) drug products and the continued need for the additional labeling will be determined when these additional studies are completed and evaluated.