MED NUMB- lidocaine hcl 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 HCL (4% w/w)

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain from dialysis medical procedures.

Directions

To apply hold the bottle over the treatment area for dialysis patients over AV Fistula or AV Graft approximately 3 to 5 inches away from the application area. Press the pump allowing the Med Numb to assist in alleviating discomfort caused by needle sticks. Wait for 2 minutes for anesthetic to take effect. Discontinue use if sensitivity occurs. Do not use on face.

Warnings

External Use Only. Avoid contact with the eyes

Keep out of reach of children

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 ATS Laboratories, LLC.

Any questions call 954-492-9898 or check out the web @ dermanumb.com

Bottle Label

MED NUMB
lidocaine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53200-010
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53200-010-01	28.35 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2015	12/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/01/2015	12/31/2017

Labeler - Atlas Tat Inc. (061275633)

Revised: 1/2018

Document Id: fc669c2c-c973-4666-a693-cf492edc5341

Set id: f65f9c69-4097-44e9-8c45-e2a2065c84ca

Version: 2

Effective Time: 20180124

Atlas Tat Inc.

Derma Numb Tattoo Anesthetic Spray

Active Ingredients

﻿Purpose

﻿Uses

﻿Directions

﻿Warnings