Centura Pharmaceuticals Inc
FDA issued a warning letter to Centura Pharmaceuticals Inc. (Lutz, FL) regarding its 'BLT 1-2-3 Cream,' a triple-combination topical anesthetic (benzocaine 20%, lidocaine HCl 4%, tetracaine 2%) marketed OTC for cosmetic procedures such as laser hair removal, microneedling, and dermal fillers. The product was found to be an unapproved new drug because it does not conform to OTC Monograph M017, which prohibits combining more than one '-caine' active ingredient, and its labeling includes indications beyond those permitted by the monograph. FDA also cited misbranding violations and raised safety concerns about increased systemic absorption when used in cosmetic settings without professional supervision. The company was directed to respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (5)
Potential Applications…The Centura Pharmaceuticals BLT Cream is potentially useful for a wide range of cosmetic and esthetic procedures, including: ∙ Dermal fillers used on small areas of skin such as hyaluronic acid (Juvederm, Restylane, Belotero Balance, Revanesse Versa) ∙ Injectable toxins (Botox, Dysport, and Xeomin injections) ∙ Esthetic facial treatments (chemical peels, laser hair removal, collagen induction therapy, eyebrow microblading, and tattoo removal).
How Centura BLT Numbing Creams Work?…When mixed before use, BLT numbing creams provide a maximum analgesic effect on the skin by keeping it numb for up to 30 minutes.
BLT numbing cream packets provide the best over-the-counter numbing cream for minimizing pain and discomfort associated with cosmetic and esthetic procedures.
BLT numbing creams are topical anesthetics consisting of benzocaine, lidocaine, and tetracaine as local analgesics for mild pain control. In cosmetic settings, topical anesthetics are widely used to alleviate pain and minimize discomfort associated with procedures like filler injectables, laser hair removal, skin resurfacing with laser and light-based devices.…BLT numbing cream packets provide the best over-the-counter numbing cream for minimizing pain and discomfort associated with cosmetic and esthetic procedures.
Centura Pharma's packaging separates each medication into its own sachet. Each sachet is 5gm in size, and is mixed just prior to application. Specifically formulated for minimally invasive surgeries such as microneedling Minimizes the pain of many procedures for patients.
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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