TKTX Company

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the labeled combinations and/or concentrations for the active ingredients identified in product labels for “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” do not conform to the conditions of use set forth in M017.

Passage 2

“TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subjects of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.