Sodium Shale Oil Sulfonate Eligibility for Inclusion in Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products for Human Use; Request for Safety and Effectiveness Data

Zusammenfassung

As part of our ongoing review of over-the-counter (OTC) drug products, we (Food and Drug Administration (FDA)) are announcing a call-for-data for safety and effectiveness information for sodium shale oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinse-off treatment for dandruff. We have reviewed a time and extent application (TEA) for SSOS and determined that it is eligible for consideration in our OTC drug monograph system. We will evaluate the submitted data and information to determine whether SSOS can be generally recognized as safe and effective (GRASE) as an OTC rinse-off treatment for dandruff.