SeeNext Venture, Ltd.
FDA issued a warning letter to SeeNext Venture, Ltd. (doing business as NumbSkin) for distributing three lidocaine numbing cream products — NumbSkin 5% Lidocaine Numbing Cream (15g and 30g) and NumbSkin 10.56% Lidocaine Numbing Cream — as unapproved new drugs and misbranded drugs. The products were marketed for use before cosmetic procedures such as tattooing, piercing, laser hair removal, and microblading, with lidocaine concentrations (5% and 10.56%) exceeding the 0.5%–4% range permitted under OTC Monograph M017, and with indications not covered by any applicable final administrative order. FDA cited serious safety concerns about increased systemic absorption when applied under plastic wrap to large or broken skin areas without professional supervision, and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (8)
Imagine getting a piercing or tattoo without any pain. The lidocaine cream 5% will make it possible. . . . Tattoo topical numbing lotion lidocaine 5% will prevent pain for up to 4 hours.
Imagine getting a piercing or tattoo without any discomfort. The lidocaine cream 10.56% will make it possible. . . . Tattoo topical numbing lotion lidocaine 10.56% can prevent discomfort for up to 4 hours.
USAGES OF LIDOCAINE 5% . . . PAIN RELIEF . . . PIERCING . . . LASER HAIR REMOVAL . . . HEMORRHOIDS . . . MICROBLADING . . . HOW TO USE NUMBING CREAM? . . . Apply a thick amount of cream and rub it in. . . . Cover with plastic wrap & keep it on for 30-45 minutes.
Efficacy/Effectiveness: . . . – topical anesthetic cream for . . . laser, waxing, tattoo, cosmetic procedures . . . – cosmetic procedures, microdermabrasion, cosmetic procedures involving needles, microneedle therapy
PROTECT YOUR SKIN DURING LASER HAIR REMOVAL . . . This pain cream works in 15-30 minutes.
NumbSkin is the most trusted brand that provides topical anesthetic products. Trusted by tattoo artists worldwide.
For temporary relief of pain and itching associated with anorectal disorders, or a local anesthetic for minor surgery, and cosmetic procedures.
Lidocaine is volatile ingredient so you should cover them with the plastic wrap to help absorbing the lidocaine into the skin. 4. After 30~60 minutes, remove plastic wrap and the cream as well. Leave the cream on the skin longer for better result. Don't remove the plastic wrap until you feel the numbing effect.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address 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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