Health Canada to add hydroquinone to the Prescription Drug List when sold in concentrations greater than 2%

Starting date:
August 29, 2017
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Identification number:
RA-64332

August 29, 2017
For immediate release

OTTAWA – Health Canada will be making certain concentrations of hydroquinone available by prescription as of August 2018. Hydroquinone is used to lighten dark spots on the skin such as age spots, liver spots or freckles.

There are a number of risks associated with skin-lightening products that contain hydroquinone at concentrations greater than 2%. Hydroquinone greater than 2% for use on the skin may:

  • cause severe skin redness, burning or stinging, dryness or cracking of the skin, blisters or oozing, or skin discolouration.
  • cause cancer in laboratory animals, and potentially in humans.
  • be harmful to the environment.

To mitigate these risks, hydroquinone at concentrations above 2% for use on the skin will be added to the Prescription Drug List. This means that these products will be available by prescription only, under the oversight of a health care professional, rather than without a prescription. It is important to note that products currently on the market and available by prescription containing higher concentrations of hydroquinone will not be affected by this change.

A number of hydroquinone products are currently available without a prescription in Canada. Health Canada is notifying manufacturers of the intent to switch products used on the skin containing greater than 2% hydroquinone to prescription status, and expects that manufacturers will begin to transition their products in anticipation of the upcoming requirements. This follows an online consultation with health authorities, industry, and consumer and professional associations, which ended in April 2017.

What you should do

  • Consult your pharmacist or your doctor for advice on whether these products are right for you, and how to use them safely.
  • Only use hydroquinone for the recommended duration as per the product label and advice from your health care provider.
  • Use sunscreen that blocks UVA and UVB after each application of hydroquinone.
  • Stop using and consult your health care provider if after using hydroquinone dark spots (hyperpigmentation) develop or get worse.
  • Do not use on large surfaces of the body or face. It is intended only for small darkened areas or spots.
  • Avoid contact with eyes, mucous membranes and broken or irritated skin. In case of contact, rinse thoroughly with water.
  • Do not use during pregnancy or if breastfeeding.
  • Do not use on children.
  • Return any unused product to your local pharmacy if you stop using it, for safe disposal.

As with all other health products that may pose a risk, Health Canada will continue to monitor the safety of products containing hydroquinone and will take any further action as necessary to help protect the health and safety of Canadians.

Report adverse events to health products to Health Canada by calling toll-free at
1-866-234-2345, or by reporting online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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