Topical Muscle and Joint Pain Relievers
September 14, 2012
FDA is warning health care providers and patients of rare reports of chemical burns associated with the use of nonprescription topical muscle and joint pain products. From 2004-2010, 43 cases of application site burns were reported to FDA. Burns ranged in severity from first-degree to third-degree, with some cases requiring hospitalization.. Some burns occurred after a single application. Patches, creams or balms containing menthol as the primary ingredient or combinations containing methyl salicylate at concentrations greater than 10% plus menthol at concentrations greater than 3% were implicated in the majority of cases. There were also a small number of burns reported with products containing capsaicin. While no products were specifically identified as having a higher risk, many commonly available products, including Icy Hot®, BenGay®, Flexall®, Mentholatum® and Capzasin®, contain the ingredients indicated the report.
FDA is not requiring the inclusion of a warning on the labeling of the products in question. These products should not cause painful sensations, blistering, or swelling. They are intended to produce a warming or cooling effect. If pain, blistering or swelling occurs, discontinue the product, and seek medical attention. Submit reports of adverse events to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Additional information is available at the following links:
- MedWatch Alert:
- FDA Drug Safety Communication:
- FDA Consumer Update:
September 14, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.