Skin Care Products
The FDA established an OTC monograph, M016, to regulate over-the-counter (OTC) skin protectant drugs. This ensures these topical products are safe and effective for minor skin conditions. The monograph outlines acceptable ingredients, like allantoin for "temporarily protecting chapped or cracked skin" or zinc oxide to dry the oozing and weeping of poison ivy, oak or sumac. It also dictates labeling requirements, so you can be confident about using the product as intended. This applies to common skin irritations like scrapes, dryness, and insect bites.
M016.10 Skin protectant active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Allantoin, 0.5 to 2 percent | M016.10 (Part 347) |
| Aluminum hydroxide gel, 0.15 to 5 percent | M016.10 (Part 347) |
| Calamine, 1 to 25 percent | M016.10 (Part 347) |
| Cocoa butter, 50 to 100 percent | M016.10 (Part 347) |
| Cod liver oil, 5 to 13.56 percent | M016.10 (Part 347) |
| Colloidal oatmeal, 0.007 percent minimum | M016.10 (Part 347) |
| Dimethicone, 1 to 30 percent | M016.10 (Part 347) |
| Glycerin, 20 to 45 percent | M016.10 (Part 347) |
| Hard fat, 50 to 100 percent | M016.10 (Part 347) |
| Kaolin, 4 to 20 percent | M016.10 (Part 347) |
| Lanolin, 12.5 to 50 percent | M016.10 (Part 347) |
| Mineral oil, 50 to 100 percent | M016.10 (Part 347) |
| Lanolin, 15.5 percent | M016.10 (Part 347) |
| Sodium bicarbonate | M016.10 (Part 347) |
| Talc,45 to 100 percent | M016.10 (Part 347) |
| Topical starch, 10 to 98 percent | M016.10 (Part 347) |
| White petrolatum, 30 to 100 percent | M016.10 (Part 347) |
| Zinc acetate 0.1 to 2 percent | M016.10 (Part 347) |
| Zinc carbonate, 0.2 to 2 percent | M016.10 (Part 347) |
| Zinc oxide, 1 to 25 percent | M016.10 (Part 347) |
| Zinc oxide, above 25 to 40 percent in an ointment dosage form. | M016.10 (Part 347) |
| Benzocaine 5 to 20 percent | M016.10 (Part 347) |
M016.12 Astringent active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Aluminum acetate, 0.13 to 0.5 percent | M016.12 (Part 347) |
| Aluminum sulfate, 46 to 63 percent | M016.12 (Part 347) |
| Witch hazel | M016.12 (Part 347) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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