CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART H—Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis (§358.701 to §358.760) > 358.710—Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

358.710—Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:
(a) Active ingredients for the control of dandruff. (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.
(2) Pyrithione zinc, 0.3 to 2 percent when formulated to be applied and then washed off after brief exposure.
(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.
(4) Salicylic acid, 1.8 to 3 percent.
(5) Selenium sulfide, 1 percent.
(6) Selenium sulfide, micronized, 0.6 percent.
(7) Sulfur, 2 to 5 percent.
(b) Active ingredients for the control of seborrheic dermatitis. (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.
(2) Pyrithione zinc, 0.95 to 2 percent when formulated to be applied and then washed off after brief exposure.
(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.
(4) Salicylic acid, 1.8 to 3 percent.
(5) Selenium sulfide, 1 percent.
(c) Active ingredients for the control of psoriasis. (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.
(2) Salicylic acid, 1.8 to 3 percent.

Code of Federal Regulations

[56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994]