21 C.F.R. § 333.210

Current through October 31, 2024

Section 333.210 - Antifungal active ingredients

The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient:

(a) Clioquinol 3 percent.

(b) Haloprogin 1 percent.

(c) Miconazole nitrate 2 percent.

(d) Povidone-iodine 10 percent.

(e) Tolnaftate 1 percent.

(f) Undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent.

(g) Clotrimazole 1 percent.

21 C.F.R. §333.210

58 FR 49898, Sept. 23, 1993, as amended at 67 FR 5943 , Feb. 8, 2002