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TKTX Numb Store distributed three unapproved topical anesthetic cream products containing lidocaine marketed for use before cosmetic procedures such as tattooing and laser treatments without FDA approval, violating sections 505(a) and 301(d) of the FD&C Act. The products were also misbranded under section 502(ee) of the FD&C Act, with lidocaine concentrations exceeding permissible OTC limits and active ingredient combinations that did not conform to the external analgesics final administrative order. The company marketed these drugs without an approved new drug application and without meeting the conditions required for nonprescription drugs under section 505G of the FD&C Act.