Coal tar/menthol dandruff shampoo to be proposed as Category I combination -- FDA.
This article was originally published in The Rose Sheet
Executive Summary
COAL TAR/MENTHOL DANDRUFF INGREDIENT COMBO TO BE DEEMED CATEGORY I (safe and effective for OTC use) in an upcoming Federal Register notice, FDA told Denorex manufacturer Whitehall-Robins in a Jan. 17 letter. Based on data submitted by Whitehall in a March 1993 citizen petition, FDA plans to amend the 1991 final monograph for OTC dandruff, seborrheic dermatitis and psoriasis drug products to include 1.8% coal tar/1.5% menthol as a Category I combination for control and relief of dandruff symptoms. A brief comment period will follow publication of the proposal; formal ruling on the petition occurs with the publication of a final rule.