Topical Products Containing Menthol Required Label Updates
By: Teri Jenner, Manager Regulatory Affairs Group, email
A safety review was recently carried out by Health Canada on over-the-counter topical counterirritant products has established a link between the use of topical pain relievers containing menthol and the risk of rare but serious skin burns. As a risk mitigation strategy, Health Canada is requesting changes to the labels for all topical natural health products containing the medicinal ingredient menthol.
Specifically, the Natural and Non-prescription Health Products Directorate (NNHPD) has recently updated the product monographs for Medicated Vapours as well as Counterirritants and is requesting updates for all topical products containing menthol.
The following risk statement is now required:
If you experience pain, swelling or blistering, stop use and get medical help right away.
Registrant are expected to update their labels as necessary to include the risk statement within the monograph by April 4, 2018.