[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR358.720]

[Page 317]
 
                        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--
 
    Subpart H_Drug Products for the Control of Dandruff, Seborrheic 
                        Dermatitis, and Psoriasis
 
Sec.  358.720  Permitted combinations of active ingredients.

    Salicylic acid identified in Sec.  358.710(a) (4) may be combined 
with sulfur identified in Sec.  358.710(a)(6) provided each ingredient 
is present within the established concentration and the product is 
labeled for the control of dandruff.

    Effective Date Note: At 72 FR 9852, Mar. 6, 2007, Sec.  358.720 was 
revised, effective Apr. 5, 2007. For the convenience of the user, the 
revised text is set forth as follows:

[Page 317]
 
                        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--
 
    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 Sec.  358.710(a)(4) may be combined with 
sulfur identified in Sec.  358.710(a)(7) provided each ingredient is 
present within the established concentration and the product is labeled 
according to Sec.  358.750.
    (b) Combination of control of dandruff and external analgesic active 
ingredients. Coal tar identified in Sec.  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 Sec.  358.760.