Rare Cases of Burns Associated with OTC Topical Muscle and Joint Pain Relievers, FDA Warns

FDA alerts the public that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries. These OTC topical muscle and joint pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin. The various formulations include creams, lotions, ointments, and patches and are marketed under brand-names such as Bengay^®, Capzasin^®, Flexall^®, Icy Hot^®, and Mentholatum^®. The products are applied to the skin and produce a local sensation of warmth or coolness; they should not cause pain or skin damage. FDA explains, however, that there have been rare cases of serious burns following their use, some with serious complications requiring hospitalization. In many cases, the burns occurred after only one application of the OTC topical muscle and joint pain reliever, with severe burning or blistering occurring within 24 hours of the first application. FDA specifies that the majority of reported second- and third-degree burns occurred with the use of products containing menthol as the single active ingredient, and products containing both menthol and methyl salicylate, in concentrations greater than 3% menthol and 10% methyl salicylate. There were few reported cases associated with a capsaicin-containing product.

FDA advises that consumers who experience pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, should stop using the product and seek medical attention immediately. The agency also provides advice for safe use of these products in an FDA Safety Alert. FDA advises that health care providers recommending OTC topical muscle and joint pain relievers to patients should counsel them about how to use the products appropriately and inform them about the risk of serious burns.