Dandruff, seborrheic dermatitis, and psoriasis drug products containing coal tar and menthol for over-the-counter human use; amendment to the monograph. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA did not receive any comments or data in response to its previously proposed rule to include this combination. This final rule is part of FDA's ongoing review of OTC drug products.
D000982:Antipruritics / Q000627:therapeutic use; D003033:Coal Tar / Q000627:therapeutic use*; D003257:Consumer Product Safety; D012628:Dermatitis, Seborrheic / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D006203:Hair Preparations; D006801:Humans; D008610:Menthol / Q000627:therapeutic use*; D004366:Nonprescription Drugs / Q000627:therapeutic use; D011537:Pruritus / Q000188:drug therapy; D011565:Psoriasis / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D000982:Antipruritics; D006203:Hair Preparations; D004366:Nonprescription Drugs; D008610:Menthol; D003033:Coal Tar