Active Ingredients
Lidocaine HCI
Derma Numb
FDA Label NDC 53200-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlas Tat Inc. for the product Derma Numb (NDC 53200-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, directions, warnings, do not use, stop use and ask a doctor if, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Uses
Temporarily relieves pain from tattoo procedures.
Directions
First test product to sensitivity to skin.
Once skin is broken or outline is done, apply derma numb generously to tattooed area.
Wait two minutes for anesthetic to take affect, re-apply derma numb to tattoo area as needed through out the tattoo process for comfort. Discontinue use if sensitivity occurs. Do not use on face.
Warnings
External Use Only
Avoid contact with the eyes
Do Not Use
If you have any known allergy or sensitivity to any of these ingredients in this product. Discontinue use and seek medical attention.
Stop Use And Ask A Doctor If
• skin becomes irritated • condition worsens or symptoms last more than7 days • symptoms clear up and reoccur with a few days
Inactive Ingredients
Water, Propylene Glycol, Achillea Millefolium (Yarrow) Extract, Yucca Glauca Root Extract, Citric Acid, Sodium Metabisulfate, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone.
Other Information
This product was manufactured for Atlas Tat, Inc.
Any questions call 954-492-9898 or check out the web @ dermnumb.com
Package Label.Principal Display Panel
Dermanumblabel_1oz_r1 (Dermanumblabel 1oz R1)
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