FDA sends warning letters to six makers of topical pain relief products

The U.S. Food and Drug Administration (FDA) warns consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during, or after certain cosmetic procedures , such as microdermabrasion, laser. waxing, tattooing and piercing. The FDA issued warning letters to six companies for marketing these products in violation of federal law.

TKTX Numb Maximum Strength Pain Relief

Some of these products are labeled because they contain ingredients, such as lidocaine, at concentrations higher than those allowed for over-the-counter topical pain relief products.
When these products containing high concentrations of lidocaine intended for use before or during certain cosmetic procedures are applied in a way that may increase the absorption of the drug through the skin, it can cause serious injuries, such as irregular heartbeats, seizures and breathing difficulties, the FDA said. These products may also interact with medications or dietary supplements that the consumer is taking, the agency says.

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

Despite the FDA’s warnings to consumers about similar products over the past decade, the agency said it continues to find potentially dangerous products available online and in retail stores. The FDA said it is not aware of any evidence that these products are safe.

In addition, the FDA says that when lidocaine is applied to large areas of skin, especially to irritated or broken skin, for extended periods of time and when the skin is covered, the product can cause serious injury.

Warning letters

The products of the warning letters are:

• 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 and Improved Blue Gel, Super Juice Superior, 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 Numb Numbing Foam Soap

The FDA has asked the companies to respond to the warning letters within 15 days of receipt indicating how they will address these issues or provide their reasoning and supporting information as to why they believe the products do not infringe the law If violations are not addressed promptly, there may be legal action, such as confiscation of products and/or a court order requiring a company to stop manufacturing and distributing infringing products. In addition, the agency has placed some of these companies on import alert to help prevent their products from entering the US and reaching consumers.

The FDA advises consumers not to use OTC pain relief products with more than 4% lidocaine on the skin; do not apply too much OTC pain relief products to large areas of skin or to irritated or broken skin; and do not wrap skin treated with over-the-counter pain relief products with plastic wrap or other dressings. The FDA states that wrapping or covering treated skin with any type of material can increase the chance of serious side effects.

The FDA said it is aware of reports of adverse events related to these products and encourages consumers and healthcare professionals to report any adverse events with the use of any drug to the Adverse Event Reporting Program from MedWatch.

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