Food and Drug Administration, HHS § 358.750

§ 358.710 Active ingredients for the § 358.720 Permitted combinations of control of , seborrheic der- active ingredients. matitis, or . (a) Combination of active ingredients The active ingredient of the product for the control of dandruff. Salicylic consists of any of the following within acid identified in § 358.710(a)(4) may be the specified concentration established combined with identified in for each ingredient: § 358.710(a)(7) provided each ingredient (a) Active ingredients for the control of is present within the established con- dandruff. (1) Coal tar, 0.5 to 5 percent. centration and the product is labeled When a coal tar solution, derivative, or according to § 358.750. fraction is used as the source of the (b) Combination of control of dandruff coal tar, the labeling shall specify the and external active ingredients. identity and concentration of the coal Coal tar identified in § 358.710(a)(1) may tar source used and the concentration be used at a concentration of 1.8 per- of the coal tar present in the final cent coal tar solution, on a weight to product. volume basis, in combination with (2) Pyrithione zinc, 0.3 to 2 percent , 1.5 percent, in a for- when formulated to be applied and then mulation provided the product is la- washed off after brief exposure. beled according to § 358.760. (3) Pyrithione zinc, 0.1 to 0.25 percent [72 FR 9852, Mar. 6, 2007] when formulated to be applied and left on the or scalp. § 358.750 Labeling of drug products for (4) , 1.8 to 3 percent. the control of dandruff, seborrheic (5) sulfide, 1 percent. dermatitis, or psoriasis. (6) Selenium sulfide, micronized, 0.6 (a) Statement of identity. The labeling percent. of the product contains the established (7) Sulfur, 2 to 5 percent. name of the drug, if any, and identifies (b) Active ingredients for the control of the product with one or more of the seborrheic dermatitis. (1) Coal tar, 0.5 to following, as appropriate: 5 percent. When a coal tar solution, de- (1) ‘‘Dandruff (insert product form)’’ rivative, or fraction is used as the or ‘‘antidandruff (insert product source of the coal tar, the labeling form)’’. shall specify the identity and con- (2) ‘‘Seborrheic dermatitis (insert centration of the coal tar source used product form)’’. and the concentration of the coal tar (3) ‘‘Psoriasis (insert product form)’’. present in the final product. (b) Indications. The labeling of the (2) Pyrithione zinc, 0.95 to 2 percent product states, under the heading ‘‘In- when formulated to be applied and then dications,’’ the phrase listed in para- washed off after brief exposure. graph (b)(1) of this section and may (3) Pyrithione zinc, 0.1 to 0.25 percent contain any of the terms listed in para- when formulated to be applied and left graph (b)(2) or (b)(3) of this section. on the skin or scalp. Other truthful and nonmisleading (4) Salicylic acid, 1.8 to 3 percent. statements, describing only the indica- (5) Selenium sulfide, 1 percent. tions for use that have been established and listed in paragraph (b) of this sec- (c) Active ingredients for the control of tion, may also be used, as provided in psoriasis. (1) Coal tar, 0.5 to 5 percent. § 330.1(c)(2) of this chapter, subject to When a coal tar solution, derivative, or the provisions of section 502 of the Fed- fraction is used as the source of the eral Food, Drug, and Cosmetic Act (the coal tar, the labeling shall specify the act) relating to misbranding and the identity and concentration of the coal prohibition in section 301(d) of the act tar source used and the concentration against the introduction or delivery for of the coal tar present in the final introduction into interstate commerce product. of unapproved new drugs in violation of (2) Salicylic acid, 1.8 to 3 percent. section 505(a) of the act. [56 FR 63568, Dec. 4, 1991, as amended at 59 (1) (‘‘For relief of’’ or ‘‘Controls’’) FR 4001, Jan. 28, 1994] ‘‘the symptoms of’’ (select one or more

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