Safety Alerts & Recalls

What does this mean?

Topical pain products can be helpful in relieving the pain in sore muscles and joints. Typically you can expect a sensation of warmth and then often a coolness that soon follows with the use of these products. If you experience a burning pain or blistering after using a topical pain reliever, you should seek medical attention immediately. Unfortunately, there is no way to predict which consumers might have this negative skin reaction.

The FDA has the following advice for consumers using OTC topical muscle and joint pain relievers, including products like Icy Hot, Bengay, Capzasin, Flexall, and Mentholatum:

- Don't apply these products onto damaged or irritated skin.

- Don't apply bandages to the area where you've applied a topical muscle and joint pain reliever.

- Don't apply heat to the area in the form of heating pads, hot water bottles or lamps. Doing so increases the risk of serious burns.

- Don't allow these products to come in contact with eyes and mucous membranes (such as the skin inside your nose, mouth or genitals).

- It's normal for these products to produce a warming or cooling sensation where you've applied them. But if you feel actual pain after applying them, look for signs of blistering or burning. If you see any of these signs, stop using the product and seek medical attention.

- If you have any concerns about using one of these products, talk to a medical professional first.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Warns OTC Topical Pain Relievers May Cause Burns to Skin

The Food and Drug Administration (FDA) has received more than 40 reports of burns associated with the use of over-the-counter (OTC) topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate and capsaicin. These OTC topical pain relievers for muscles and joints include creams, lotions, ointments and patches sold under brand names such as Icy Hot, Bengay, Capzasin, Flexall, and Mentholatum.

In many cases, burns occurred after just one application of the product, with severe burning or blistering occurring within 24 hours. Some had complications serious enough to require hospitalization.

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Source: FDA
Publication Date: 2012-09-14
Last Updated: 2012-09-14

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