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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2019]
[CITE: 21CFR358.720]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

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

Sec. 358.720 Permitted combinations of active ingredients.

(a) Combination of active ingredients for the control of dandruff. Salicylic acid identified in 358.710(a)(4) may be combined with sulfur identified in 358.710(a)(7) provided each ingredient is present within the established concentration and the product is labeled according to 358.750.

(b) Combination of control of dandruff and external analgesic active ingredients. Coal tar identified in 358.710(a)(1) may be used at a concentration of 1.8 percent coal tar solution, on a weight to volume basis, in combination with menthol, 1.5 percent, in a shampoo formulation provided the product is labeled according to 358.760.

[72 FR 9852, Mar. 6, 2007]

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