FDA Issues Warning on Certain OTC Analgesic Topical Products

Posted By Madilyn Moeller, Wednesday, April 3, 2024

Laser tattoo removal

The U.S. Food and Drug Administration has issued a warning to consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law.

Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. When these products that contain high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties. These products may also interact with medications or dietary supplements a consumer is taking.

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