LIDOCARE 03- 4% lidocaine patch 
NFI, LLC

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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Lidocaine Back Patch

Active Ingredients

Lidocaine 4%

Purpose

Topical anesthetic

Use

For the temporary relief of pain.

Warnings

For external use only.

Do not use if pouch is damaged or opened. Do not use

on large areas of the body or on cut, irritated skin
on open wounds or sensitive skin
for more than one week without consulting a doctor
do not use if you are allergic to lidocaine or any of the inactive ingredients listed below.

When using this product

use only as directed. Read and follow all directions and warnings on this package.
do not allow contact with the eyes
do not bandage or apply local heat (such as heating pads) to the area of use
do not reuse patch.

Stop use and ask doctor if

condition worsens
rash, itching or skin irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children and pets.

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

Directions

Adults and children over 12 years of age: Apply patch to affected area every 8 to 12 hours.
Children 12 years or younger: Consult a physician before use.

Instructions for Use

clean and dry affected area
cut open pouch and remove the patch
remove clear protective liner from the patch
apply to affected area no more than three (3) times per day
leave in place for up to 8 but no more than 12 hours
wash hands thoroughly after applying or removing patch
some individuals may not experience pain relief until several minutes or hours after applying a patch
do not use other local anesthetic products in addition to Lidocare.

Storage Information

protect from freezing or excessive heat
store at 68°-77°F (20°-25°C).

Inactive Ingredients

Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive, vanillyl butyl ether.

PRINCIPAL DISPLAY PANEL – 3 Patch Carton Label

FROM THE MAKERS OF BLUE-EMU®
 
Lidocare™
4% LIDOCAINE

PAIN RELIEF
PATCH

BACK/SHOULDER
 
PATENT PENDING
PRESSURE ADHESIVE
PATCH
PATCH SIZE
2.5” x 6”
 
MADE IN
THE USA
 

ULTRA-FLEXIBLE
ODOR-FREE
FOR THE TEMPORARY RELIEF OF PAIN
 
3 PATCHES
1 PATCH PER POUCH
 
 
DISTRIBUTED BY:
NFI CONSUMER PRODUCTS
501 Fifth Street
Bristol, TN 37620
Toll Free: 800-432-9334
WWW.LIDOCARE.COM

image-01
LIDOCARE  03
4% lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69993-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
3-(L-MENTHOXY)-2-METHYLPROPANE-1,2-DIOL (UNII: 649M1Y2P72)  
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69993-400-033 in 1 CARTON05/01/2016
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2016
Labeler - NFI, LLC (121681919)
Establishment
NameAddressID/FEIBusiness Operations
ProSolus, Inc.969793079MANUFACTURE(69993-400)

Revised: 5/2023
Document Id: 46bf15ae-d13d-4154-a435-b9952e567126
Set id: 416ebf5a-2efb-6d0b-e054-00144ff88e88
Version: 4
Effective Time: 20230504
 
NFI, LLC