The U.S. Food and Drug Administration has warned against certain over-the-counter analgesic or pain relief products by six companies citing potential for dangerous health effects.
These products are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing.
Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for OTC, topical pain relief products.
Increased absorption of the drug product through the skin may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties. These products may also interact with other medications or dietary supplements.
In addition, lidocaine, when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time and when the skin is covered, may cause serious injury.
The agency issued warning letters to six companies for marketing unapproved, misbranded products in violation of federal law.
The companies and products in the warning letters include TKTX Co.’s 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.’s 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.’s Signature Tattoo Numbing Cream and Miracle Numb Spray.
Sky Bank Media, LLC, doing business as Painless Tattoo Co.’s Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray.
Dermal Source, Inc.’s New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1.
And, Indelicare, doing business as INKEEZE’s Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap.
Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said, “These products pose unacceptable risks to consumers and should not be on the market. We are committed to using all available tools to stop the sale of these illegal high-risk products.”
The companies are asked to respond to the warning letters within 15 days of receipt stating their plans to address these issues or provide their reasoning and supporting information for these products.
The FDA noted that failure to address violations promptly may result in legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing violative products.
Some of these companies are also placed on import alert to help stop their products from entering the U.S. and reaching consumers.
The agency further urged consumers not to use OTC pain relief products with more than 4% lidocaine on their skin, not to apply OTC pain relief products heavily over large areas of skin or to irritated or broken skin; and not to wrap skin treated with OTC pain relief products with plastic wrap or other dressings.
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