Skip to main content

Topical Pain Relievers May Cause Burns

On this page:

If you've ever rubbed a topical pain reliever—a cream, gel or other product applied to the skin—on a sore muscle or joint, you're familiar with the sensation of warmth or coolness that soon follows.

But if, instead, you experience burning pain or blistering, you must seek medical attention immediately.

The Food and Drug Administration (FDA) is warning that some consumers have reported receiving serious skin injuries while using certain over-the-counter (OTC) pain relievers applied to the skin to relieve mild muscle and joint pain.

The injuries, while rare, have ranged from mild to severe chemical burns with use of such brand-name topical muscle and joint pain relievers as Icy Hot, Bengay, Capzasin, Flexall, and Mentholatum.

OTC topical pain relievers for muscles and joints include creams, lotions, ointments and patches. In many cases, burns where the product was applied occurred after just one application, with severe burning or blistering occurring within 24 hours. Some had complications serious enough to require hospitalization.

"There's no way to predict who will have this kind of reaction to a topical pain reliever for muscles and joints," says Jane Filie, M.D., a medical officer in FDA's Division of Nonprescription Regulation Development (DNRD).

back to top

More than 40 Reported Cases

According to FDA chemist Reynold Tan, Ph.D., there have been 43 reported cases of burns associated with the use of OTC topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate and capsaicin. These cases were uncovered by FDA scientists during safety surveillance of FDA's adverse event reporting database and the medical literature.

This is a very small number of cases when compared to the number of people who purchase these products, Tan notes.

Menthol, methyl salicylate and capsaicin create sensations of local warmth or coolness, but should not burn.

According to the available data, a majority of the more severe burns occurred with the use of a menthol or menthol/methyl salicylate combination product. Most of these cases involved products that contain higher concentrations of menthol and methyl salicylate (greater than 3% menthol or 10% methyl salicylate). Few of the cases involved capsaicin.

back to top

Safety Do's and Don'ts

FDA has the following advice for consumers using OTC topical muscle and joint pain relievers:

Posted Sept. 13, 2012

Return to FDA Consumer Articles

For more information about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/consumers.