SeeNext Venture, Ltd.

Selected passages from the FDA letter

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

Passage 1

NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

Passage 2

NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they 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.

Passage 3

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

Passage 4

Claims on your products described above related to the temporary relief of pain and swelling due to tattooing, laser hair removal, or other pain sensitive procedures go beyond merely describing the general intended uses for external analgesic drug products.

Passage 5

Your products are labeled as both external analgesics and anorectal products. Your products cannot meet the requirements of both M017 and M015 with lidocaine as an active ingredient at or above a concentration of 5%.