DERMA NUMB- lidocaine hydrochloride 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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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_4oz

DERMA NUMB
lidocaine hci spray

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE)	LIDOCAINE HYDROCHLORIDE	40 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM METABISULFITE
PROPYLENE GLYCOL
EDETATE DISODIUM
ACHILLEA MILLEFOLIUM
YUCCA GLAUCA ROOT
DIAZOLIDINYL UREA

Packaging
#	Item Code	Package Description
1	NDC:53200-001-04	113.4 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)

Revised: 09/2012

Document Id: 2e1427f8-9166-42e6-a375-76e40d8c07c6

Set id: 64d07724-9e74-4320-9471-f9cdc80de7a4

Version: 1

Effective Time: 20120912

Atlas Tat Inc.

Active Ingredients

﻿Purpose

﻿Uses

﻿Directions

﻿Warnings