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Coal tar/menthol dandruff shampoo will be proposed as Category I combination -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

COAL TAR/MENTHOL DANDRUFF SHAMPOO WILL BE PROPOSED CATEGORY I (safe and effective for OTC use) in an upcoming Federal Register notice, FDA informed Denorex maker 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.
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