Health Canada to Add Hydroquinone to Prescription Drug List

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.

Consult your pharmacist or your doctor for advice on whether these products are right for you, and how to use them safely.

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.

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