§346.18. Astringent active ingredients.
21 C.F.R. § 346.18
The active ingredient of the product consists of any of the following when used within the concentration range established for each ingredient:
Calamine, within a concentration range of 5 to 25 percent by weight per dosage unit (based on the zinc oxide content of calamine).
Witch hazel, 10 to 50 percent.
Zinc oxide, within a concentration range of 5 to 25 percent by weight per dosage unit.
Notes, amendments, and revision history
Amendments
[55 FR 31779, Aug. 3, 1990, as amended at 59 FR 28767, June 3, 1994]
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.
Amendments
[55 FR 31779, Aug. 3, 1990, as amended at 59 FR 28767, June 3, 1994]