TKTX USA

Selected passages from the FDA letter

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

Passage 1

These products are marketed without an approved application under section 505 of the FD&C Act for indications that are not included in a final administrative order issued under section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application.

Passage 2

These concentrations are above the 0.5% to 4% concentration range of lidocaine permitted in M017.

Passage 3

Neither epinephrine nor prilocaine are permitted as active ingredients in M017. Moreover, prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.

Passage 4

Indications related to tattooing, piercing, and laser cosmetic or surgical procedures are not included in M017 or any other final administrative order in accordance with section 505G.

Passage 5

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 subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.