INK-EEZE Tattoo Black Label Numbing Spray Lot #: L0211

Product Description:

INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.

Reason for Recall:

Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.

Product Quantity: 2849 Bottles

Code Information: Lot #: L0211

Recalling Firm:

Indelicare LLC
914 Tourmaline Drive
Newbury Park, CA 91320
United States

Recall Initiation Date: 5/23/2013

Full Details: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=118460