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TKTX Company distributed unapproved lidocaine-based numbing products marketed for use before cosmetic procedures including tattooing, laser treatments, and permanent makeup without an approved New Drug Application, violating section 505(a) of the FD&C Act. The products were also misbranded under section 502(ee) of the FD&C Act, with lidocaine concentrations exceeding allowable limits for over-the-counter external analgesics and active ingredient combinations that did not conform to FDA's external analgesics final administrative order. The company marketed these drugs through its website (tktxcompany.com) for indications not covered under the nonprescription drug regulations governing section 505G.