By Ted Rosen, MD
The U.S. Food and Drug Administration has issued a warning regarding select over-the-counter topical analgesics, typically used before, during, or after certain cosmetic procedures such as microdermabrasion, laser hair removal, tattooing, tattoo removal, and skin piercing. It is possible that some of us recommend/sell/dispense/use the products listed in this warning (see below). Most of these are flagged because they contain concentrations of lidocaine that are higher than what is permitted. This may, in turn, put patients at risk for serious injury, including irregular heartbeat, seizures, and breathing difficulties. The products (and their manufacturers) include:
Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1
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.
SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30g), and NumbSkin 10.56% Lidocaine Numbing Cream
Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray
TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40%, and J-CAIN cream [LIDOCAINE] 29.9%
Because these products have now been publicly identified as potentially problematic, should any of us recommend/sell/dispense/use them and an injury occurs, medicolegal liability would likely be significant and quite difficult to avoid.
To learn more, visit: https://shorturl.at/wBQRY.
Ted Rosen, MD, is a Professor of Dermatology at Baylor College of Medicine in Houston, TX, and the Medical Editor of the Dermatology Digest.
