The Canadian monograph sets out the ingredients, quantities, uses and labelling for diaper rash products that can be licensed without further evidence. Products with zinc oxide, calamine, kaolin, allantoin or corn starch are natural health products. Products with dimethicone, mineral oil or petrolatum are non-prescription drugs. Zinc oxide is permitted at 1 to 25 percent, or 25 to 40 percent as zinc oxide ointment. Every medicinal ingredient in Table 1 must be pharmacopoeial grade. The monograph prints no metal limit. It refers finished-product specifications for the natural health product stream to the NNHPD Quality of Natural Health Products Guide.
Key numbers
Table 1 (natural health product medicinal ingredients): allantoin 0.5 to 2 percent; calamine (iron oxide mixed with zinc oxide) 1 to 25 percent; kaolin 4 to 20 percent; corn starch 10 to 98 percent; zinc oxide 1 to 25 percent, or 25 to 40 percent as zinc oxide ointment. Table 2 (complementary, safety only): cod liver oil 5 to 14 percent, and anhydrous lanolin 15.5 percent. Neither may be the sole medicinal ingredient. Cod liver oil must not supply more than 3000 µg RAE vitamin A and 10 µg vitamin D per day. Table 3 (non-prescription drug ingredients): dimethicone 1 to 30 percent, mineral oil 50 to 100 percent, petrolatum and white petrolatum 30 to 100 percent. The subpopulations are infants from 0 to 1 year through adults. The direction for all products is to apply liberally to a clean, dry diaper area as needed.
Methods (brief)
This is a regulatory monograph. The dosage references are US FDA 2021 (the OTC monograph), Krinsky 2017, Sweetman 2017, and Leung and Foster 2010. Use of novel technology such as nanotechnology takes a product outside the monograph.
Evidence fitness
The monograph supports the Canadian composition envelope. It supports the link to the Quality Guide’s topical heavy-metal limits (arsenic 3, cadmium 3, lead 10, total mercury 1, antimony 5 ppm) for licensed zinc oxide diaper products. For the non-prescription drug stream, specifications fall under the Food and Drug Regulations.
Limitations
The monograph requires the zinc oxide to be pharmacopoeial grade but does not name the pharmacopoeia or restate its impurity limits.
Related evidence
- Diaper Cream, ZnO-Based
- Diaper Cream, Non-ZnO
- Quality of Natural Health Products Guide
- Health Canada natural health product heavy-metal quality limits
Update history
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