DERMA NUMB- lidocaine hci spray

Derma Numb by

Drug Labeling and Warnings

Derma Numb by is a Prescription medication manufactured, distributed, or labeled by Atlas Tat Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCI

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMA NUMB 
lidocaine hci spray

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53200-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53200-001-01	28.35 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/15/2012

Labeler - Atlas Tat Inc. (061275633)