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FDA warns of some over-the-counter topical pain relief products

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Posted at 4:38 PM, Mar 28, 2024

(WXYZ) — The U.S. Food and Drug Administration is warning consumers about the dangers of some topical pain relief products that have not been approved by the agency.

These over-the-counter products have the potential to cause serious health issues.

We’re talking about external analgesics used to relieve pain before, during or after certain cosmetic procedures like microdermabrasion, laser hair removal, tattooing and piercing.

The FDA has a couple of reasons for alerting consumers about these products. First, they’re being sold without the agency’s approval of their application. And secondly, some of the ingredients are at higher concentrations than the FDA permits for over-the-counter topical pain relief products.

For instance, some of the labels show high levels of lidocaine. Too much absorption of this drug through the skin can lead to serious health issues such as an irregular heartbeat, seizures and breathing difficulties.

There’s also concern these products could interact negatively with medications or dietary supplements taken by the consumer.

The topical pain relief products are made by these companies:

  • TKTX Company
  • SeeNext Venture, Limited
  • Tattoo Numbing Cream Company
  • Painless Tattoo Company
  • Dermal Source, Incorporated
  • Ink Eeze

You can see a list of all of the product names on the FDA’s website at fda.gov,
The FDA has sent warning letters to the six companies mentioned to let them know they are in violation of federal law. They have 15 days to respond with how they will address these issues or to explain why they feel the products are not in violation of the law.

Otherwise, the FDA will consider legal action including seizing the product or stopping its production and distribution.

Meanwhile, the FDA has these recommendations for consumers:

  • Do not use over-the-counter topical pain relief products containing more than 4% lidocaine.
  • Do not apply these external products heavily or use on irritated or broken skin.
  • If you use a topical analgesic, do not wrap your treated skin with plastic wrap or other dressings.

The FDA is also asking consumers and health professionals to report any adverse reactions to these products — or to any drug — to the MedWatch Adverse Event Reporting Program on its website.

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