# FDA WARNING_LETTER - TKTX Numb Store - March 04, 2025

Source: https://www.keypedia.com/records/warning_letter/tktx-numb-store/d58466b4-ef65-4278-aead-eaf3c3115ee7

> FDA WARNING_LETTER for TKTX Numb 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 Numb 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 a firm distributing "TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]," "TKTX plus 200% More Volume," and "TKTX RAPID NUMB & LONG LASTING" via www.tktxnumbstore.com. These products, marketed as external analgesics for sensitive cosmetic procedures like tattooing and piercing, are deemed unapproved new drugs and misbranded.

The violations include:
1.  **Unapproved New Drugs:** The products are not generally recognized as safe and effective (GRASE) and lack FDA approval. They do not conform to the Over-the-Counter (OTC) Monograph M017 for external analgesics.
    *   **Lidocaine Concentration:** All products contain 5% lidocaine, exceeding the M017 permissible range of 0.5% to 4%.
    *   **Unauthorized Active Ingredients:** "TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]" and "TKTX plus 200% More Volume" contain prilocaine and epinephrine, which are not permitted by M017 or any other 505G final administrative order.
    *   **Unapproved Indications:** Labeling claims for tattooing, piercing, and laser cosmetic procedures are

## Related Officers

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

Company: https://www.keypedia.com/companies/tktx-numb-store/2f6c4ca3-bb4b-45eb-82aa-db5ee1f2530a

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