Alert on OTC Topical Pain Relievers

Over-The-Counter Topical Muscle and Joint Pain Relievers: Drug Safety Communication - Rare Cases of Serious Burns


AUDIENCE: Consumer, Health Professional

ISSUE: FDA is alerting 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, ranging from first- to third-degree chemical burns, where the products were applied. When applied to the skin, the products produce a local sensation of warmth or coolness.These products should not cause pain or skin damage, however, there have been rare cases of serious burns following their use. Some of the burns had serious complications requiring hospitalization


BACKGROUND: OTC topical muscle and joint pain relievers are used to temporarily relieve minor muscle and joint aches and pain. These OTC topical muscle and joint pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin, and are marketed under various brand-names, such as, Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum. The various formulations include creams, lotions, ointments, and patches.


RECOMMENDATION: Consumers using an OTC topical muscle and joint pain reliever who experience signs of skin injury where the product was applied, such as pain, swelling, or blistering of the skin, should stop using the product and seek medical attention immediately. When recommending OTC topical muscle and joint pain relievers to patients, healthcare professionals should counsel patients about how to use the products appropriately and inform them about the risk of serious burns.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe dicalProducts/ucm319353.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).