Centura Pharmaceuticals Inc

Selected passages from the FDA letter

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

Passage 1

Your “BLT 1-2-3 Cream” is distributed as a combination of three packets containing benzocaine 20%, lidocaine HCl 4%, and tetracaine 2%, respectively. Your website states, “Empty the contents of each sachet gradually and mix them thoroughly to ensure even distribution of the pack contents” and includes a video instructing users to mix the three packets together prior to use as well. While benzocaine at a concentration range of 5% to 20%, lidocaine HCl from 0.5% to 4%, and tetracaine from 1% to 2% are permitted active ingredients in M017, the monograph does not permit a combination of more than one “-caine” type active ingredient in a single drug product.

Passage 2

Furthermore, labeling for your “BLT 1-2-3 Cream” includes indications that are not consistent with the permitted indications for an external analgesic drug product in M017. For example, claims on your product identified above describe its use for sensitive cosmetic procedures, such as laser hair removal and tattoo removal treatments, go beyond merely describing the general intended uses for an external analgesic drug product as set forth in M017.50(b).