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www.fdanews.com/articles/213457-six-fda-warning-letters-prompted-by-high-levels-of-lidocaine-in-otc-numbing-products

Six FDA Warning Letters Prompted by High Levels of Lidocaine in OTC Numbing Products

March 29, 2024

Six manufacturers of numbing gels, creams and sprays marketed to relieve pain from cosmetic procedures have received FDA Warning Letters for concentrations of lidocaine in their products in excess of the allowance of 4 percent for OTC topical pain relief products.

The products are marketed to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing, the FDA said in a news statement.

The agency said it has been warning consumers about the danger of these products since 2009, but it “continues to find potentially dangerous products available online and in retail stores. The FDA is not aware of evidence demonstrating these products are safe.”

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