Drugs

FDA Warns Against Topical OTC Analgesics

FDA has issued a warning to not use certain over-the-counter analgesic 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 also issued Warning Letters (see below) 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,” an FDA release says. “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,” it says, adding that the products may also interact with other drug products or dietary supplements.

Warning Letters were issued to:

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 (30 grams) 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
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

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