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

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83559-005

Active Ingredient

Camphor 80mg
Menthol 24mg
Capsicum Extract 16mg

Purpose

Topical analgesic

Use

For temporary relief of pains

Warnings

For external use only

Do not use

·Do not get into eyes or on mucous membranes
·Do not apply to wounds, damaged or irritated skin
·Do not bandage or cover with any type of wrap except clothing
·Do not use with a heating pad or apply external heat
·Do not use 1 hour prior to bathing or within 30 minutes after bathing

When Using

·Use only as directed

Stop Use

·Condition worsens
·Severe skin irritation occurs
·Pain persists for more than 7 days
·Symptoms clear up and occur again within a few days

Ask Doctor

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.
Children under 12 years, consult doctor before use

Keep Out Of Reach Of Children

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

Directions

·Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
·Children under 12 years, consult doctor before use
How to apply:
·Clean and dry affected area
·Cut open pouch and remove patch
·Remove protective film and apply directly to area of pain
·Apply to affected area not more than 3 times daily
·Wash hands with soap after applying patch
·Reseal pouch containing unused patches

Other information

This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.

Inactive ingredients

Aluminum Glycinate, Ethylhexylglycerin, Eucalyptus Oil, Glycerin, Kaolin, Mentha Oil, Phenoxyethanol, Polyvinylpyrrolidone,Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol Solution, Tartaric Acid, Water

Questions

1-800-910-6874

PRINCIPAL DISPLAY PANEL

1324

PAIN RELIEF PATCH 
pain relief patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83559-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)80 mg  in 100 
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM16 mg  in 100 
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24 mg  in 100 
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
KAOLIN (UNII: 24H4NWX5CO)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POVIDONE (UNII: FZ989GH94E)  
TARTARIC ACID (UNII: W4888I119H)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83559-005-015 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(83559-005)

Revised: 4/2024
Document Id: 1592d29d-e276-a44d-e063-6294a90ab17d
Set id: 1592d29d-e275-a44d-e063-6294a90ab17d
Version: 1
Effective Time: 20240408
 
Henan Enokon Medical Instrument Co., Ltd.