FDA to issue proposed rule for certain OTC shampoos

December 19, 2005

The FDA is issuing a proposed rule to amend the final monograph (FM) for OTC dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8% coal tar solution and 1.5% menthol in a shampoo drug product to control dandruff. The agency is issuing this proposed rule after considering information submitted in a citizen petition. In 1993, FDA received a petition to amend the FM for OTC dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 9% coal tar solution and 1.5% menthol in a shampoo drug product to relieve scalp itching associated with dandruff. To submit electronic comments by March 9, 2006, visit http://www.regulations.gov/.