FDA Issues Warning Letters for Over-the-Counter Pain Relief Products with Dangerous Lidocaine Levels

Popular Pain-Relief Creams Pose Dangerous Health Risks, FDA Warns

In recent years, the popularity of over-the-counter topical pain-relief products has grown rapidly. However, a new warning from the U.S. Food and Drug Administration (FDA) is shedding light on the potential dangers of these products. According to the FDA, six companies have been issued warning letters for marketing unapproved, misbranded products with higher-than-allowed concentrations of lidocaine, which can cause serious side effects like an irregular heartbeat, seizures, and breathing issues.

Lidocaine is a common local anesthetic that is used in many cosmetic procedures to alleviate some of the pain associated with these treatments. However, when used in excessive amounts or on large portions of skin or irritated skin, it can cause serious injury or even death. That’s why the FDA recommends using only topical pain-relief products containing no more than 4% lidocaine and avoiding wrapping them onto the skin with dressings or plastic wraps.

The FDA’s warning applies to several popular over-the-counter topical pain-relief products such as TKTX Numb Maximum Strength Pain Reliever, TKTX During Procedure Numbing Gel and J-CAIN cream, NumbSkin Lidocaine Numbing Creams, Signature Tattoo Numbing Cream and Miracle Numb Spray, Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray, New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1

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