Hydroquinone in Canada, from 4% prescription to 2% NPN creams
Hydroquinone is legal in Canada by strength: over 2% needs a prescription, 2% or less is a licensed NHP, and cosmetics can't use it to lighten skin.
Hydroquinone in Canada and which strengths are legal to sell
Hydroquinone in Canada is legal. Which rule applies depends on strength and on the product type. On skin, Health Canada treats it as a prescription drug above 2% and a natural health product at 2% and under. A natural health product needs a licence, shown as an eight-digit NPN. Cosmetics are a separate route, and skin lightening is not on it.
The Cosmetic Ingredient Hotlist allows hydroquinone only in hair dyes, nail products and lash or brow extension adhesives. A hydroquinone serum or fade cream sold as a cosmetic does not comply at any strength.
| Route | Hydroquinone allowed | What you need |
|---|---|---|
| Prescription drug | Topical on skin, above 2% (for example 4%) | DIN, prescription, Schedule I |
| Natural health product | Topical, up to 2% | NPN (8 digits) |
| Cosmetic | Hair dye 0.3%, nail products 0.1%, lash and brow adhesive 0.1% | Hotlist limits and label cautions |
Hydroquinone 4% has been prescription only since June 30, 2019
Canada's Prescription Drug List covers "Hydroquinone or its derivatives" when sold "in a concentration greater than 2% in preparations for topical use on the skin." The notice of amendment is dated October 1, 2018 and took effect on June 30, 2019. An earlier 2017 notice of intent proposed 12 months from its date. Health Canada later moved the effective date, so June 30, 2019 is the date to use.
The September 2018 advisory says that from June 30, 2019, products containing hydroquinone greater than 2% need a prescription. Health Canada's stated hydroquinone side effects for high-strength products are that they can "cause severe skin redness, burning or stinging" and may "cause cancer in laboratory animals, and potentially in humans."
The NAPRA National Drug Schedules place hydroquinone or its derivatives in Schedule I when sold at more than 2% in preparations for topical use on the skin. That entry was approved June 30, 2019 and is footnoted as following the Prescription Drug List.
ERFA hydroquinone 4%
The Drug Product Database lists ERFA Hydroquinone, DIN 02491702, as a 4% w/w topical gel from Searchlight Pharma Inc. The schedule is Prescription, the status is marketed, and the monograph is dated 2022-09-29. It is a gel, not a cream.
Hydroquinone 2% is an NPN, not a leftover DIN
The NHP Ingredients Database entry sets the topical medicinal upper limit at 2.0%. A topical skin preparation above 2% is not an NHP. The product also has to meet applicable Hotlist restrictions unless the applicant submits extra safety evidence.
There is no single-ingredient monograph for hydroquinone or for skin lightening, so each licence rests on that product's evidence. NPN 80141338, "Crème 2% Hydroquinone" from Functionalab Group inc., is active and was licensed on May 28, 2025, but the market status is Not Marketed. NPN 80040474 is 2.0% hydroquinone with kojic acid. A licence is not proof the tube is on a shelf. In the Licensed Natural Health Products Database, market notification is voluntary, and "Not Marketed" is the default when the company supplies nothing.
Older 2% products held DINs as non-prescription drugs, including Drula, Porcelana, Esoterica, Palmer's and Ambi. About 50 of those DINs are cancelled, the last of them between 2021 and 2024. A new 2% product needs an NPN. Check your provincial pharmacy regulator before supplying a licensed 2% product.
Hotlist limits for hydroquinone in cosmetics
The Cosmetic Ingredient Hotlist (2025 edition, page modified 2025-08-13) lists hydroquinone, CAS 123-31-9, as restricted, not prohibited. Three uses are allowed:
- Oxidizing colouring agent in hair dyes, up to 0.3%. The cautions are "Avoid skin contact", "Do not use to dye eyelashes or eyebrows", and "Rinse eyes immediately if the product comes into contact with eyes".
- Nail products, up to 0.1%. If p-hydroxyanisole is also present, the two together may not exceed 0.1%.
- Cyanoacrylate adhesives for eyelash and eyebrow extensions, up to 0.1%.
Nail products and those adhesives must carry "Avoid skin contact" and "Read directions carefully before using". In May 2024 the Hotlist change log extended nail use beyond professional artificial nail systems, changed the limit, and added the combined hydroquinone and p-hydroxyanisole cap. A reference that still quotes 0.02% for professional nail systems is out of date.
Skin lightening is not a permitted cosmetic use. A leave-on fade cream or brightening serum may not contain hydroquinone. Health Canada describes the Hotlist as an administrative tool for ingredients that may not comply with the Food and Drugs Act or the Cosmetic Regulations. It is not a drug authorization.
How to check a hydroquinone product is authorized
An authorized skin-treatment product shows an eight-digit DIN or NPN on the label. Match the DIN to the Drug Product Database, or the NPN to the Licensed Natural Health Products Database, and confirm the record is active. "Not Marketed" on an NPN does not mean the licence is dead.
Health Canada's unauthorized skin lightening advisory (updated March 26, 2025) lists products labelled with hydroquinone and tretinoin. Brilliant Skin Essentials Brilliant Rejuv Set was removed from sale at Hiraya Filo Store in Victoria, B.C. (added August 7, 2024). On September 13, 2023, Kolorete Canada in Vancouver had Brilliant Rejuv and a Dr. Alvin depigmenting product seized. Selling unauthorized health products is illegal. Health Canada tells people to stop using listed products and to consult a health care professional with concerns.
You can also ask RegAffairs AI about hydroquinone in Canada and open each cited Health Canada page.