Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient

Resumo

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following conditions as part of FDA's ongoing review of over-the-counter (OTC) drug products: Climbazole, 0.1 to 0.5 percent and 0.5 to 2.0 percent, as a dandruff control active ingredient in leave-on and rinse-off dosage forms, respectively. FDA has reviewed a time and extent application (TEA) for these conditions and determined that they are eligible for consideration in its OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether these conditions can be generally recognized as safe and effective (GRASE) for their proposed OTC use.