Menthol-based products: Labeling Standard Revision

Health Canada is informing Canadians that a safety review has established a risk of serious burns with the use of some over-the-counter (OTC) topical pain relievers containing menthol.

These pain relievers/counterirritants are applied to the skin to help relieve muscle and joint pain. They may contain several active ingredients and are available in different sort of formulations, such as creams, gels, liquids and patches.

Pharmacovigilance activities have allowed to establish an associated risk with more serious effects like skin burns, pain, blistering or other severe skin damage with topical pain relievers containing menthol.

In response to this concern, Health Canada will publish an updated labelling standard for all menthol-containing topical pain relievers in the coming weeks. Manufacturers will have to update their products labelling accordingly to better inform consumers about the risk of these products.

Contact Consultpharm experts’ team for more information and to assist you to comply with this new requirement.