Hydroquinone in Canadian Cosmetics

Yes. In Canada, 4% hydroquinone for use on the skin is a prescription drug. Health Canada's Prescription Drug List covers "hydroquinone or its derivatives" when sold at a concentration greater than 2% in preparations for topical use on the skin (PDL notice). At 2% or below it is not on the List.

The Drug Product Database shows the same split

• The 4% product on the market today is prescription-only. ERFA Hydroquinone (DIN 02491702) is a 4% w/w topical gel from Searchlight Pharma Inc., Montreal ^{[2][3][4][5][6]}. Its schedule is Prescription ^[7], and it has been marketed since 29 September 2022 ^[8].
• Older 4% products were also prescription-only. I checked nine 4% products that are now cancelled, and every one was scheduled Prescription. Examples: ^[9][10][11].
• Lower strengths were non-prescription. I checked six cancelled products at 1.5% to 2%, and all were scheduled Non-prescription. Examples: ^[12][13].

Timing and practical points

• Two official dates don't match. The PDL notice is dated 29 August 2017 and says the change takes effect 12 months after that date. Health Canada's later advisory of 25 September 2018 gives 30 June 2019 as the date a prescription became required for products above 2% (advisory). Either way, the requirement has been in force for years.
• Products at 2% or less were, according to that advisory, available over the counter "behind pharmacy counters".
• Why it's prescription-only: the advisory says these products can "cause severe skin redness, burning or stinging" and "cause cancer in laboratory animals, and potentially in humans".
• Cosmetics are a separate route. As covered earlier, a cosmetic can't be a skin lightener at any strength. A 4% product can only be sold in Canada as a prescription drug with a DIN.

Approach: I searched Health Canada's Drug Product Database for every hydroquinone product's strength and schedule. The Prescription Drug List itself isn't in the datasets, so I took its wording from Health Canada's PDL notice and the 2018 advisory on canada.ca.

Sources:

• Notice – Prescription Drug List (PDL): Hydroquinone, Health Canada
• Health Canada reminds Canadians to consult a health professional before using high-concentration hydroquinone products

Hydroquinone at 2% or less doesn't need a prescription in Canada, but it is still regulated as a drug, so it needs a DIN. I found no such product on the market today. The current national pharmacy schedule entry covers only strengths above 2%. Health Canada's Drug Product Database lists 50 hydroquinone products at 2% or less, and every one is cancelled.

What the schedules say

• NAPRA's National Drug Schedules list "hydroquinone or its derivatives" as Schedule I (prescription) only when sold at more than 2% in preparations for use on the skin. The entry was approved on 30 June 2019 and is noted as following the federal Prescription Drug List (NAPRA entry). That page has no entry for strengths of 2% or less.
• The 30 June 2019 approval date matches the date in Health Canada's 2018 advisory, which settles the date mismatch from my last answer. The advisory also said products at 2% or less stayed available "behind pharmacy counters".
• A 2% product still can't be sold as a cosmetic. The Cosmetic Ingredient Hotlist allows hydroquinone only in hair dyes, nail products and lash or brow extension adhesives ^[1]. A 2% fade cream has to be a non-prescription drug with a DIN.

What the Drug Product Database shows

• Nothing at 2% or less is marketed now. The only marketed hydroquinone product is the 4% prescription gel from my last answer ^[3].
• All 50 lower-strength products are cancelled. 47 were 2%, two were 1.5% and one was 1.8%. 48 of them carry a Non-prescription schedule, for example ^[14][15]. The other two have no schedule recorded: Phaze 13 Light N' Block Pigment Cream ^[16] and Clear-N-Smooth ^[17].
• The last ones to go:

Product (DIN)	Strength	Status history
Drula Fade Cream Extra-Medicated (01933965) [18]	2%	Dormant 1 Aug 2018 [19]; cancelled (annual notification not returned) 8 Jan 2024 [20]
Drula Fade Cream Medium-Medicated (01933949) [21]	1.8%	Dormant 1 Aug 2018 [22]; cancelled 8 Jan 2024 [23]
Drula Fade Cream Normal-Medicated (01933957) [24]	1.5%	Dormant 1 Aug 2018 [25]; cancelled 8 Jan 2024 [26]
Zarina Skin Lightening Cream with Sunscreening Filter (02266490) [27]	2%	Cancelled (annual notification not returned) 20 Dec 2021 [28]
Clear Essence Medicated Fade Cream (02239114) [29]	2%	Cancelled (annual notification not returned) 20 Dec 2021 [30]

The table shows the 5 most recently cancelled of the 50. The rest were cancelled between 1997 and 2018, including the Esoterica, Palmer's, Porcelana, Nadinola, Ambi, Black Opal and Dermablend fade creams.

What this means:

• Selling a product: a 2% hydroquinone cream needs its own DIN as a non-prescription drug. No DIN at that strength is currently active.
• Buying one: I found nothing authorised to buy over the counter at that strength.
• If you find one on sale anyway: Canadian databases don't show it as authorised. It may be an import, a cosmetic making drug claims, or a product whose DIN has lapsed.

Approach: I checked every hydroquinone record in Health Canada's Drug Product Database for strength, schedule and status history, and read NAPRA's National Drug Schedules entry on its website. I didn't check Quebec's separate provincial drug schedules.

Sources:

• NAPRA National Drug Schedules: Hydroquinone or its derivatives