Health Canada reminds Canadians to consult a health professional before using high-concentration hydroquinone products

Starting date:
September 25, 2018
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-67812

September 25, 2018
For immediate release

OTTAWA – Hydroquinone is used to lighten dark spots on the skin such as age spots, liver spots or freckles. However, Health Canada recommends that products for use on the skin that contain high concentrations of hydroquinone be used with caution and only under the supervision of a health care professional.

There are a number of risks associated with skin-lightening products that contain hydroquinone at concentrations greater than 2%. 

These products 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; and,
  • be harmful to the environment.

While these products are currently accessible behind the counter in most pharmacies, Health Canada announced in August 2017 that it intends to add products for use on the skin that contain hydroquinone at concentrations above 2% to the Prescription Drug List.  The Department has extended the coming into force date of this prescription status to June 30, 2019, in order for products to remain available to those who require them, and to enable the companies to fully address the necessary regulatory requirements for this transition. As of June 30, 2019, products containing hydroquinone greater than 2% will require a prescription from a health care practitioner to be sold in Canada.

It is important to be aware that these products should be used with caution.

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.
  • Use hydroquinone only for the recommended duration as per the product label and advice from your health care provider.
  • Use sunscreen that blocks UVA and UVB rays after each application of hydroquinone.
  • Stop using hydroquinone and consult your health care provider if dark spots (hyperpigmentation) develop or get worse after using the product.
  • If there are symptoms of skin inflammation such as redness, burning or stinging, please discontinue use of the product and consult your health care provider.
  • Do not use on children.
  • 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.
  • Return any unused product to your local pharmacy if you stop using it, for safe disposal.

Health Canada will continue to monitor the safety of products containing hydroquinone and will take any further action needed to help protect the health and safety of Canadians.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

  • Call toll-free at 1-866-234-2345.
  • Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report 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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