§347.20. Permitted combinations of active ingredients. — Inbound Citations

(e) Cod liver oil, 5 to 13.56 percent, in accordance with § 347.20(a)(1) or (a)(2), provided the product is labeled so that the quantity used in a 24-hour period does not exceed 10,000 U.S.P. Units vitamin A and 400 U.S.P. Units cholecalciferol.

(e) Cod liver oil, 5 to 13.56 percent, in accordance with § 347.20(a)(1) or (a)(2), provided the product is labeled so that the quantity used in a 24-hour period does not exceed 10,000 U.S.P. Units vitamin A and 400 U.S.P. Units cholecalciferol.

(f) Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4).

(39) September 6, 2010, for products subject to paragraph (a)(18)(ii) of this section that contain calcium acetate monohydrate, except as provided in § 347.20(b) of this chapter.

(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “astringent.” For products containing the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in § 347.20(b), under the “Purpose” heading identified in § 201.66(c)(3) of this chapter, the labeling of each active ingredient in the product states “Astringent”, which is followed by the statements “ When combined together in water, these ingredients form the active ingredient aluminum acetate. See [the following in bold italic type] Directions.”