Dermal Source, Inc.

Warning LetterOpen

Mary Jane Haake President Dermal Source, Inc. 2319 NE Glisan St Portland , OR 97232 United States info@dermalsource.comIssued Mar 25, 2024Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateMar 25, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Dermal Source, Inc.
Location: Mary Jane Haake President Dermal Source, Inc. 2319 NE Glisan St Portland , OR 97232 United States info@dermalsource.com
FEI Number: N/A
Country: United States
Issue Date: March 25, 2024
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Dermal Source, Inc. distributed five unapproved topical anesthetic products (NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1) marketed for use before cosmetic procedures such as tattooing and piercing without an approved new drug application, violating section 505(a) of the FD&C Act. The products were also misbranded under section 502(ee) and contained lidocaine concentrations exceeding permissible limits for over-the-counter external analgesics or included unapproved active ingredient combinations. The FDA identified these violations through a website review conducted in September 2023.

Dermal Source, Inc. FDA Warning Letter, March 25, 2024