FDA Says Certain OTC Topical Analgesics Pose Health Risk

The Food and Drug Administration (FDA) has issued warning letters to 6 companies for selling unapproved, misbranded, over-the-counter (OTC) analgesic products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures (eg, microdermabrasion, laser hair removal, tattooing and piercing).

The Companies were flagged for marketing the following products:

• TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%;
• SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30g) and NumbSkin 10.56% Lidocaine Numbing Cream;
• Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray;
• Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray;
• Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1; and
• Indelicare, doing business as INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap. 

According to the FDA, some of these OTC analgesic products may contain concentrations of lidocaine that are higher than what is permitted, which may put consumers at risk for serious injury, including irregular heartbeat, seizures, and breathing difficulties.  

The FDA states that consumers should not use OTC pain relief products with more than 4% lidocaine on their skin. Moreover, these products should not be applied heavily over large areas of skin or to irritated or broken skin. Consumers should also not wrap skin treated with these products with plastic wrap or other dressings.

“These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”