# FDA WARNING_LETTER - Dermal Source, Inc. - March 26, 2024

Source: https://www.keypedia.com/records/warning_letter/dermal-source-inc/e0cc513f-c175-4245-a704-cba53e087372

> FDA WARNING_LETTER for Dermal Source, Inc. on March 26, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dermal Source, Inc.
- Inspection Date: 2024-03-26
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On March 25, 2024, the FDA issued a Warning Letter to Ms. Haake regarding the distribution of unapproved and misbranded drug products: NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1. These products, marketed as external analgesics for sensitive cosmetic procedures (e.g., tattooing, piercing), were identified through a September 2023 website review (https://dermalsource.com/).

The FDA found these products to be unapproved new drugs under section 505(a) of the FD&C Act and misbranded under section 502(ee). Violations include:
- **Unapproved New Drugs**: The products are marketed without an approved application and for indications not covered by the external analgesics final administrative order (M017) under section 505G.
- **Excessive Active Ingredient Concentrations**: Lidocaine HCl concentrations (5%) exceed the M017 permissible range (0.5%-4%).
- **Impermissible Active Ingredient Combinations**: NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, and PREMIUM PRO PLUS combine multiple "-caine" type active ingredients (e.g., lidocaine, tetracaine, benzocaine), which is not permitted by M017.
- **Unapproved Indications**: Claims for pain relief during tattooing, permanent

## Related Officers

- [Director](https://www.keypedia.com/people/jill-p-furman/984bfbfc-3f4e-46bc-8d3b-3d82e56c6ac9)

Company: https://www.keypedia.com/companies/dermal-source-inc/37e2af4b-b78d-495b-a910-c31b6421bdfe

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