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

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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Active Ingredient

Borneol 1%

Purpose

Topical analgesic

Use

Temporarily relieves minor pain associated with: arthritis, simple backache, muscle strains, bruises

Warnings

For externaluse only Keep out ofreach of children Pregnant, breast-feeding, people with severe chronicdiseases or allergic to the raw materials are forbidden to use

Do not use

If you feel unwell, please deal with it in time

When Using

Use only as directed
Do not bandage tightly or use with a heating pad Avoid contact with eyes or mucous membranes
Do not apply to wounds or damaged skin

Stop Use

Ask Doctor

Condition worsen
Symptoms persist more than 7 days or clear up and occur again within a few days
Skin irritation develops

Keep Oot Of Reach Of Children

Do not leave the product within reach of unconscious persons.

Directions

Adults and children 12 years of age and older: apply to affected area no more than 12 hours per timeChildren under 12 vear ofage: consult a doctorPeel off back protective film and alian the stainless steel ball with the affected area and apply patch, pressingpatch to skin for secure adhesion

Other information

Store the product in a cool, dry and well-ventilated placeAvoid direct sunlight

Inactive ingredients

Camphor (Synthetic), Menthol,Capsaicin,Chuanxiong Rhizoma, Cinnamon, Paeonia LactifloraRoot,Caryophyli Flos, Lycopodii Herba, Carthami Flos, Olibanum, Myrrha, Notopteryqii RhizomaEt Radix,Achyranthis Bidentatae Radix

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

0102

ENOKON PAIN RELIEF PATCH 
pain relief patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83559-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL1 g  in 100 
Inactive Ingredients
Ingredient NameStrength
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
CLOVE (UNII: K48IKT5321)  
MYRRH (UNII: JC71GJ1F3L)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
CINNAMON (UNII: 5S29HWU6QB)  
LYCOPODIUM JAPONICUM TOP (UNII: CI148ZPI0D)  
ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)  
MENTHOL (UNII: L7T10EIP3A)  
INCISED NOTOPTERYGIUM RHIZOME OR ROOT (NOTOPTERYGIUM FRANCHETII) (UNII: KRT28P6ITK)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CAPSAICIN (UNII: S07O44R1ZM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83559-002-011 in 1 BAG; Type 0: Not a Combination Product06/28/2023
2NDC:83559-002-023 in 1 BAG; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01606/28/2023
Labeler - Henan Enokon Medical Instrument Co Ltd. (701730676)
Establishment
NameAddressID/FEIBusiness Operations
Henan Enokon Medical Instrument Co Ltd.701730676manufacture(83559-002)

Revised: 6/2023
Document Id: ff416fb0-3c91-4bc9-e053-6394a90a5447
Set id: ff416fb0-3c90-4bc9-e053-6394a90a5447
Version: 1
Effective Time: 20230629
 
Henan Enokon Medical Instrument Co Ltd.