CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR347.10]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 347 -- SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart B - Active Ingredients

Sec. 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.