§ 347.10. Skin protectant active ingredients.
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/us/cfr/t21/s§ 347.10·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The active ingredients of the product consist of any of the following, within the concentration specified for each ingredient:
(a)Allantoin, 0.5 to 2 percent.
(b)Aluminum hydroxide gel, 0.15 to 5 percent.
(c)Calamine, 1 to 25 percent.
(d)Cocoa butter, 50 to 100 percent.
(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).
(g)Dimethicone, 1 to 30 percent.
(h)Glycerin, 20 to 45 percent.
(i)Hard fat, 50 to 100 percent.
(j)Kaolin, 4 to 20 percent.
(k)Lanolin, 12.5 to 50 percent.
(l)Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4).
(m)Petrolatum, 30 to 100 percent.
(n)[Reserved]
(o)Sodium bicarbonate.
(p)[Reserved]
(q)Topical starch, 10 to 98 percent.
(r)White petrolatum, 30 to 100 percent.
(s)Zinc acetate, 0.1 to 2 percent.
(t)Zinc carbonate, 0.2 to 2 percent.
(u)Zinc oxide, 1 to 25 percent.
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