The U.S. Food and Drug Administration (FDA) issued warning letters to six companies marketing unapproved over-the-counter topical analgesics. The FDA explained that the products were designed to reduce pain before, during, and after cosmetic procedures such as microdermabrasion, laser hair removal, tattooing, and piercing. However, the analgesics were found to have higher concentrations of lidocaine than permitted in over-the-counter products, which may cause arrhythmia, seizure, and breathing difficulties, or interact negatively with other drugs—especially when applied over large areas of irritated or broken skin for long periods of time. The six companies revealed to be in violation of the FDA’s regulations were TKTX Company, SeeNext Venture, Tattoo Numbing Cream, Sky Bank Media operating as Painless Tattoo, Dermal Source, and Indelicare operating as INKEEZE. The companies that received the warning letters were asked to respond within 15 days with their rationale for supplying products with high concentrations of lidocaine. The FDA advised individuals who do decide to use over-the-counter analgesics to avoid those containing greater than 4% lidocaine, only apply them to small areas of the skin, and refrain from wrapping the skin in plastic wrap or other dressings after application. The agency requested that health-care providers and patients report all adverse events following the use of over-the-counter analgesics to its MedWatch Adverse Event Reporting program. “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,” concluded Jill Furman, JD, Director of the Office of Compliance at the Center for Drug Evaluation and Research at the FDA.