The monograph sets the permitted medicinal ingredients, quantities, dosage forms, uses, directions, warnings, and specifications for diaper rash products that can be authorised in Canada without submitting further evidence. It prints no metal values. It matters for this collection because it decides which specification regime covers a diaper-rash powder, oil, or lotion.
Key numbers
| Class | Ingredients (quantity) | Specification route |
|---|---|---|
| Natural health product, Table 1 | allantoin (0.5-2%), calamine (1-25%), kaolin (4-20%), corn starch (topical starch, 10-98%), zinc oxide (1-25%; 25-40% as ointment); each must be pharmacopoeial grade | finished-product specifications per the NNHPD Quality of Natural Health Products Guide |
| Natural health product, Table 2 (complementary, safety only) | cod liver oil (5-14%), anhydrous lanolin or lanolin (15.5%) | same |
| Non-prescription drug, Table 3 | dimethicone (1-30%), mineral oil or white mineral oil (50-100%), petrolatum or white petrolatum (30-100%) | requirements of the Regulations under the Food and Drugs Act |
Acceptable dosage forms for natural health products include cream, gel, lotion, oil, ointment, paste, powder, salve, solution, topical liquid, and medicated wipe. Non-prescription drug forms are cream, gel, lotion, oil, ointment, paste, solution, and wipe, so powder is available only as a natural health product. Subpopulations run from infants 0 to 1 year to adults.
For all powder products the label must warn to keep powder away from the face to avoid inhalation, which can cause breathing problems, and not to use on broken skin.
Scope and basis
Heavy metal limits reach a diaper-rash product only through its specification route. A corn-starch or kaolin powder authorised as a natural health product follows the topical limits of the Quality of Natural Health Products Guide (see Quality of Natural Health Products Guide). A mineral-oil or petrolatum product is a non-prescription drug and follows the drug regulations instead.
Evidence fitness
The monograph supports the classification and labelling of diaper-rash powders, oils, and ointments in Canada. It is not a source of metal values.
Related evidence
- Diaper Cream, ZnO-Based
- Diaper Cream, Non-ZnO
- Baby Powder, Cornstarch-Based
- Baby Oil
- Quality of Natural Health Products Guide
Update history
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