Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis

The Food and Drug Administration (FDA) outlines specific regulations for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis treatments through a monograph system. This system, designated as OTC Monograph M032, dictates which ingredients are generally recognized as safe and effective for these conditions. Common ingredients approved by M032 include coal tar, salicylic acid, selenium sulfide, and pyrithione zinc at specified concentrations. Each product's labeling must adhere to the monograph's guidelines, including directions for use and warnings. This system ensures that these OTC products meet safety and efficacy standards for managing these scalp conditions.

Active ingredients for the control of dandruff
Active Ingredients OTC Monograph Number
Coal tar, 0.5 to 5 percentM032.10 (Part 358)
Pyrithione zinc, 0.3 to 2 percent when formulated to be applied and then washed off after brief exposureM032.10 (Part 358)
Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalpM032.10 (Part 358)
Salicylic acid, 1.8 to 3 percentM032.10 (Part 358)
Selenium sulfide, 1 percentM032.10 (Part 358)
Selenium sulfide, micronized, 0.6 percentM032.10 (Part 358)
Sulfur, 2 to 5 percentM032.10 (Part 358)
Active ingredients for the control of seborrheic dermatitis
Active Ingredients OTC Monograph Number
Coal tar, 0.5 to 5 percentM032.10 (Part 358)
Pyrithione zinc, 0.95 to 2 percent when formulated to be applied and then washed off after brief exposureM032.10 (Part 358)
Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalpM032.10 (Part 358)
Salicylic acid, 1.8 to 3 percentM032.10 (Part 358)
Selenium sulfide, 1 percentM032.10 (Part 358)
Active ingredients for the control of psoriasis.
Active Ingredients OTC Monograph Number
Coal tar, 0.5 to 5 percent M032.10 (Part 358)
Salicylic acid, 1.8 to 3 percentM032.10 (Part 358)

These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.

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