LIDOCAINE PAIN RELIEF PATCH- lidocaine pain relief patch patch 
Henan Enokon Medical Instrument Co., Ltd.

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83559-004

Active Ingredient

Lidocaine 4%

Purpose

Topical analgesic

Use

For temporary relief of pain

Warnings

For external use only

Do not use

more than 1 patch at a time
on wounds or damaged skin
with a heating pad
if you have ever had an allergic reaction to this product or any of its ingredients

When Using

use only as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly

Stop Use

localized skin reactions occur, such as rash, itching, redness, irritation, pain swelling and blistering conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.
Children under 12 years of age: consult a doctor

Keep Out Of Reach Of Children

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

Directions

Adults and children 12 years of age and over
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor

Other information

avoid storing product in direct sunlight
protect product from excessive moisture
store at 20-25°C(68-77°F)

Inactive ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water

Questions

1-800-910-6874

PRINCIPAL DISPLAY PANEL

12

LIDOCAINE PAIN RELIEF PATCH 
lidocaine pain relief patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83559-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TARTARIC ACID (UNII: W4888I119H)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83559-004-016 in 1 BOX; Type 0: Not a Combination Product04/07/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/07/2024
Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)
Establishment
NameAddressID/FEIBusiness Operations
Henan Enokon Medical Instrument Co., Ltd.701730676manufacture(83559-004)

Revised: 4/2024
Document Id: 1592a40a-a648-34bd-e063-6394a90a0a10
Set id: 1592a40a-a647-34bd-e063-6394a90a0a10
Version: 1
Effective Time: 20240408
 
Henan Enokon Medical Instrument Co., Ltd.