The U.S. Food and Drug Administration (FDA) has warned the public to avoid using certain over-the-counter topical products marketed to relieve pain before, during, or after specific cosmetic procedures, including microdermabrasion, laser hair removal, tattooing, and piercing. The agency has issued warning letters to six companies responsible for manufacturing these products, citing violations of federal law due to containing higher concentrations of lidocaine than permitted. The high amount of lidocaine in these products could lead to increased absorption through the skin, potentially causing serious injuries such as irregular heartbeat, seizures, and breathing difficulties, according to the FDA. TKTX Company for TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10 percent Lidocaine, TKTX Dring Procedure Numbing Gel 40 percent, and J-CAIN Cream (Lidocaine) 29.9 percent; SeeNext Venture, Ltd. for NumbSkin 5 percent Lidocaine Numbing Cream (15-gram and 30-gram sizes) and NumbSkin 10.56 percent Lidocaine Numbing Cream; Tattoo Numbing Cream Co. for Signature Tattoo Numbing Cream and Miracle Numb Spray; Sky Bank Media, LLC, doing business as Painless Tattoo Co., for Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray; Dermal Source Inc. for New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine, and Maximum Zone 1; and Indelicare, doing business as INKEEZE, for Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label, and Ink Eeze B Numb Numbing Foam Spray. The FDA has warned consumers in the past about the risks of lidocaine-based pain-relieving products. In February 2007, the agency issued an advisory describing the deaths of two women, aged 22 and 25, who used lidocaine-based topical anesthetics before laser hair removal. They applied the topical anesthetics to their legs to decrease the pain during the procedure. As instructed, they wrapped their legs in plastic wrap to increase the anesthetic drugs’ effect. According to the public health advisory, both
Women experienced seizures, fell into comas, and subsequently died from the toxic effects of the drugs, noting that the skin-numbing creams contained high amounts of lidocaine as well as tetracaine.