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PAIN RELIEF PATCHES by Amerisource Bergen

Medically reviewed on July 1, 2017

Dosage form: patch
Ingredients: LIDOCAINE 4g in 100g
Labeler: Amerisource Bergen
NDC Code: 46122-450

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.

PAIN RELIEF PATCHES

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

Temporarily relieves minor pain.

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

■ carefully remove smaller portion of backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 12 hours. Children under 12 years of age: consult a physician.

Warnings

For external use only.

Idications and Usage

Uses: Temporaily relieves minor pains.

When using this product

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not microwave

■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

If pregnant or breastfeeding, ask a health professional before use.

Do not Use

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away.

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,
Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

TOLL-FREE

Customer Care Help Line
866-326-1313
Mon–Fri 8:30 am–4:30 pm CST

DIST. BY
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
www.mygnp.com


Made in China

PAIN RELIEF PATCHES 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-450
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Aluminum 
Glycerin 
Kaolin 
Methylparaben 
POLYACRYLIC ACID (300000 MW) 
POLYSORBATE 80 
Propylene Glycol 
Propylparaben 
PVP/VA COPOLYMER 
SODIUM POLYACRYLATE (2500000 MW) 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:46122-450-215 PATCH in 1 CARTON
19 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2017
Labeler - Amerisource Bergen (007914906)
Establishment
NameAddressID/FEIOperations
Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(46122-450)

 
Amerisource Bergen

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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