[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR358.710]

[Page 298]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
    Subpart H--Drug Products for the Control of Dandruff, Seborrheic 
                        Dermatitis, and Psoriasis
 
Sec. 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.

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

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