DERMA NUMB- lidocaine hci spray 
Atlas Tat Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Derma Numb Tattoo Anesthetic Spray

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

DermaNumbLabel_1oz_r1

DERMA NUMB 
lidocaine hci spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53200-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53200-001-0128.35 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/15/2012
Labeler - Atlas Tat Inc. (061275633)

Revised: 10/2012
Document Id: a5d9e551-6401-4b22-b7fc-92031b40c295
Set id: 84c65be3-bee5-4da1-aba5-38779a6d9cdc
Version: 1
Effective Time: 20121003
 
Atlas Tat Inc.