CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART B—Active Ingredients (§347.10 to §347.20) > 347.10—Skin protectant active ingredients.

347.10—Skin protectant active ingredients.

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.