Derma Numb Spray

Generic Name: lidocaine hydrochloride
Dosage Form: topical spray

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.

Derma Numb Tattoo Anesthetic Spray

Active Ingredients

Lidocaine HCI

Purpose

Topical Anesthetic

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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

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:53200-001-01 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)
Revised: 10/2012
 
Atlas Tat Inc.



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