Sky Bank Media, LLC dba Painless Tattoo Cream Co.
FDA issued a warning letter to Sky Bank Media, LLC dba Painless Tattoo Cream Co. for distributing PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY as unapproved new drugs and misbranded products. The products contain lidocaine at 5% concentration and combinations with prilocaine and epinephrine that exceed or fall outside OTC monograph M017 permissible conditions, and are marketed for cosmetic procedures (tattooing, piercing, laser treatments) not covered by any FDA final administrative order. FDA cited safety concerns about increased dermal absorption during cosmetic procedures and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (8)
Get Tattooed Without ANY Pain
OTHER USES FOR PAINLESS TATTOO SPRAY…- Tattoo Removal - Microblading - Permanent Cosmetics - Burns - Wounds - Itching
OTHER USES FOR PAINLESS TATTOO…- Tattoo Removal - Microblading - Laser Hair Removal - Permanent Cosmetics - Waxing - Injections - Piercings - Lip Fillers - Blood Tests - Vaccinations
Painless Tattoo Spray will keep the area numb for 1-3 hours depending on your skin type and location on the body.
STOP PAIN - Our Painless Tattoo Numbing Cream relieves pain anywhere it's applied for 3+ hours
We make tattoo clients happy by eliminating pain
Drug Facts . . . Suggested Use . . . For the temporary relief of pain associated with itching, swelling, inflammation or discomfort… Directions: . . . Apply a generous amount of cream to the desired area, wrap area with plastic wrap, wait 45 minutes for full effect.
You (or your client) will be completely pain-free, FAST
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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