OTC Monograph M016, posted September 24, 2021, is FDA Final Administrative Order OTC000005 for skin protectant drug products for over-the-counter human use. The order was effective on March 27, 2020, upon enactment of the CARES Act. Section M016.10 permits aluminum hydroxide gel at 0.15 to 5 percent, calamine at 1 to 25 percent, kaolin at 4 to 20 percent, talc at 45 to 100 percent, zinc acetate at 0.1 to 2 percent, zinc carbonate at 0.2 to 2 percent, and zinc oxide at 1 to 25 percent, with zinc oxide above 25 to 40 percent only in an ointment. Section M016.12 permits aluminum acetate at 0.13 to 0.5 percent in the solution used by the consumer and aluminum sulfate at 46 to 63 percent on the anhydrous equivalent. Sodium bicarbonate is listed in M016.10(o) with no concentration. Titanium dioxide is not an active ingredient in this monograph. The monograph states no heavy-metal contaminant limit.
Key numbers
| Analyte | Matrix | Value | Unit | Statistic | N | Where |
|---|---|---|---|---|---|---|
| Aluminum hydroxide gel | OTC skin protectant drug product | 0.15 to 5 | percent | permitted concentration range | § M016.10(b) p.2 | |
| Calamine | OTC skin protectant drug product | 1 to 25 | percent | permitted concentration range | § M016.10(c) p.2 | |
| Kaolin | OTC skin protectant drug product | 4 to 20 | percent | permitted concentration range | § M016.10(j) p.3 | |
| Sodium bicarbonate | OTC skin protectant drug product | not specified | percent | permitted concentration | § M016.10(o) p.3 | |
| Talc | OTC skin protectant drug product | 45 to 100 | percent | permitted concentration range | § M016.10(p) p.3 | |
| Zinc acetate | OTC skin protectant drug product | 0.1 to 2 | percent | permitted concentration range | § M016.10(s) p.3 | |
| Zinc carbonate | OTC skin protectant drug product | 0.2 to 2 | percent | permitted concentration range | § M016.10(t) p.3 | |
| Zinc oxide | OTC skin protectant drug product | 1 to 25 | percent | permitted concentration range | § M016.10(u) p.3 | |
| Zinc oxide | OTC skin protectant ointment | above 25 to 40 | percent | permitted concentration range | § M016.10(v) p.3 | |
| Aluminum acetate | OTC astringent solution as used by the consumer | 0.13 to 0.5 | percent | permitted concentration range | § M016.12(a) p.3 | |
| Aluminum sulfate | OTC astringent drug product | 46 to 63 | percent | permitted concentration range | § M016.12(b) p.3 | |
| Aluminum acetate | OTC astringent solution prepared from powder or tablet | 0.13 to 0.5 | percent | permitted concentration range | § M016.20(b) p.4 |
Methods (brief)
The monograph sets permitted active-ingredient concentrations and labeling. Source note: 58 FR 54462, October 21, 1993, unless otherwise noted, with later amendments cited in the text. Combinations in M016.20 require each skin protectant ingredient to remain within the M016.10 concentration, except the aluminum acetate solution prepared under M016.20(b).
Basis: percent of the finished topical drug product, except aluminum acetate (solution used by the consumer) and aluminum sulfate (anhydrous equivalent)
Evidence fitness
This source can support: Permitted percent ranges for metal and metal-compound active ingredients in US OTC skin protectant and astringent drug products under Monograph M016; Identification that M016 states no heavy-metal contaminant limit.
It cannot support: A heavy-metal impurity specification for these OTC products; Elemental composition of calamine, kaolin, or talc; Occurrence of lead or other metals in finished skin protectants; A titanium dioxide limit or permitted percent.
Limitations
No heavy-metal contaminant limit is stated anywhere in Monograph M016. There is no numerical maximum for lead, arsenic, cadmium, mercury, antimony, or any other elemental impurity. Titanium dioxide does not appear. Calamine, kaolin, and talc are named as ingredients with permitted percents; the monograph does not give their elemental composition. Sodium bicarbonate has no permitted percent. This record does not treat non-metal actives (allantoin, cocoa butter, cod liver oil, colloidal oatmeal, dimethicone, glycerin, hard fat, lanolin, mineral oil, petrolatum, white petrolatum, topical starch, or witch hazel) as metal limits.
Related evidence
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