The FDA has issued warnings about the risk of severe chemical burn injuries caused by topical pain relievers, including Icy Hot. These products contain chemicals that produce a gentle “warming” sensation, but instead, they could potentially cause second- or third-degree burns, severe pain, swelling, scarring, and disfigurement, which may require hospital treatment. Unfortunately, the warning label does not include this risk information.

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What is Icy Hot?

Icy Hot is an over-the-counter topical anesthetic that produces a cooling/warming sensation when applied to the skin. The active ingredients include menthol and methyl salicylate in various amounts, depending on the product. They cause small blood vessels near the surfaces of the skin to dilate, producing a warming sensation and increasing blood flow to the area.

Some of the more powerful Icy Hot products include:

Icy Hot Ultra Strength Cream: 10% menthol, 30% methyl salicylateIcy Hot Patch: 5% mentholIcy Hot Roll: 7.5% mentholIcy Hot Sleeve 16% mentholIcy Hot Balm: 7.6% menthol, 29% methyl salicylate

FDA Warning for Icy Hot

In September 2012, the U.S. Food and Drug Administration (FDA) published a Safety Communication regarding Icy Hot and other topical painkillers. An investigation of medical literature and the FDA’s adverse event report database revealed 43 confirmed cases of burns associated with topical pain relievers. Several of these burn injuries required hospitalization for second- or third-degree burns.

The most serious burn injuries occurred with products containing primarily menthol, or at least 3% menthol and 10% methyl salicylate. Several types of Icy Hot contain concentrations of menthol and/or methyl salicylate that exceed this amount. However, the label on Icy Hot does not warn about the risk of burn injuries.

The FDA warned that topical pain relievers should be used with caution, and they should not cause pain. The agency also warned:

Do not use the product under a tightly wrapped bandageDo not use the product on skin that is broken, damaged, or irritatedDo not use the product in combination with another source of heat, such as a hot water bottle, heating pad, or lampDo not use the product if it causes any pain, burning, or irritation of the skin

Icy Hot Chemical Burns

A chemical burn occurs when a chemical causes tissue damage. Chemical burns caused by topical anesthetics are most serious when the product remains in contact with the skin for a prolonged period of time. If Icy Hot causes a burn, the product should be removed from the skin immediately. A second- or third-degree chemical burn can cause severe pain, scarring, and potentially permanent disfigurement. The burn may require hospitalization for treatment.

Stop using Icy Hot immediately if you suffer any of the following symptoms of a chemical burn:

PainInflammationSwellingDiscoloration of the affected area (redness)Blisters on the skin

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