TKTX USA
FDA issued a warning letter to TKTX USA on February 25, 2025, concerning five topical numbing cream products (Blue, Green, Black, Gold, and Yellow TKTX Numbing Creams 40%) marketed for use before cosmetic procedures such as tattooing, microblading, and laser treatments. The products were found to be unapproved new drugs because they contain lidocaine at concentrations (20–40%) far exceeding the 0.5–4% permitted under OTC Monograph M017, and include non-permitted active ingredients (prilocaine, epinephrine) in non-permitted combinations. FDA also cited misbranding violations and raised safety concerns about increased systemic absorption through broken or irritated skin during cosmetic procedures. TKTX USA was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.
Flagged claims (9)
Cover the area with a plastic wrap to enhance absorption.
This cream, known for its authentic quality, skillfully alleviates pain and discomfort linked to various skin procedures, including cosmetic treatments, tattoo applications, and laser hair removal. With a standing as a top choice in the realm of pain relief, its effectiveness and quality are evident. When applied as directed, it maintains its numbing effect for up to 04 hours.
TKTX Green Numbing Cream 40% is a topical anesthetic with a potent formula designed to numb the skin effectively. The "40%" indicates the strength of active agents in the cream, which is formulated to provide maximum pain relief for skin procedures that may otherwise be quite painful.
Introducing the powerful TKTX Black Numbing Cream, a trusted ally in pain management since its inception. Specially formulated for maximum efficiency, this cream is an ideal solution for easing discomfort associated with a wide range of skin procedures such as tattoos, cosmetic treatments, and laser hair removal. Recognized for its exceptional quality, TKTX Black sets the standard in pain relief, providing a numbing effect that lasts for a full four hours when applied correctly.
Blue TKTX Numbing Cream is a topical anesthetic designed to numb the skin surface, effectively reducing pain and discomfort associated with dermal procedures. It is widely used in various cosmetic and medical applications to provide temporary relief from pain and itching.
Green: This variant has a 40% concentration of lidocaine and is recommended for use on sensitive areas such as the face, neck, and genitals…
Gold TKTX Numbing Cream is typically utilized for: ∙Extensive tattooing sessions. ∙Piercings in sensitive areas. ∙Cosmetic procedures that may cause significant discomfort, such as deep laser treatments and extensive waxing. ∙Minor surgical interventions that do not require injectable anesthesia….
Blue TKTX Numbing Cream is used during: ∙Tattoo application and removal. ∙Body piercing. ∙Cosmetic procedures like microblading and lip fillers. ∙Laser hair removal and other laser treatments. ∙Minor surgical procedures and injections…
Gold TKTX Numbing Cream 40% is a highly concentrated topical anesthetic cream that provides significant numbing effects for skin procedures. The "40%" indicates a potent blend of active ingredients designed to deliver an intense level of numbness for an extended period of time, making it suitable for more painful procedures where deep numbing is essential.
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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