# FDA WARNING_LETTER - TKTX Store - March 04, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/tktx-store/7a459912-4950-4e24-b319-77201327252a

> FDA WARNING_LETTER for TKTX Store on March 04, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: TKTX Store
- Inspection Date: 2025-03-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On February 25, 2025, the FDA issued a Warning Letter to Ms. Chan regarding the distribution of "Mithra+ 10% Lidocaine," "J-PRO Cream," and all TKTX branded numbing products. These products are marketed as external analgesics for use before sensitive cosmetic procedures like tattooing and microblading, and are sold without a prescription via tktxstore.com and Instagram.

The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act, and are misbranded under section 502(ee). The products are considered drugs due to their intended use for pain relief and affecting body function.

Key violations include:
- **Unapproved New Drugs:** The products lack FDA approval and do not conform to the Over-the-Counter (OTC) monograph M017 for external analgesics or M015 for anorectal drug products.
- **Unapproved Indications:** Claims for tattooing, piercing, and laser cosmetic procedures are not included in any OTC monograph.
- **Excessive Active Ingredient Concentrations:** "Mithra+ 10% Lidocaine" exceeds permissible lidocaine concentrations. "J-PRO Cream" combines lidocaine and prilocaine, which is not permitted. TKTX products contain prilocaine (not an acceptable OTC ingredient) and epinephrine at concentrations not

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.globalkeysolutions.net/companies/tktx-store/17b2c91d-0822-4356-b227-577d29d2ce66

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c