ENOKON PAIN RELIEF PATCH-ACUPOINT PRESSURE STIMULATION- pain relief patch-acupoint pressure stimulation 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

Warnings

For externaluse onlyKeep out ofreach of childrenPregnant, 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 directedDo not bandage tightly or use with a heating padAvoid contact with eyes or mucous membranesDo not apply to wounds or damaged skin

Stop Use

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

Ask Doctor

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

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

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

Inactive ingredients

camphor iSvnthetic), Menthol Capsaicin, Chuanxiong Rhizoma, Cinnamon, Paeonia .actiflora PootCaryophyli Flos, Lycopodii Herba, Carthami Flos, Olibanum, Myrrha, Notopterygii Rhizoma Et Radix,Achyranthis Bidentatae Radix

Questions

(86)0373-4901688

INDICATIONS

Muscle ache

PRINCIPAL DISPLAY PANEL

0102

ENOKON PAIN RELIEF PATCH-ACUPOINT PRESSURE STIMULATION 
pain relief patch-acupoint pressure stimulation patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83559-001
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
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
INCISED NOTOPTERYGIUM RHIZOME OR ROOT (NOTOPTERYGIUM FRANCHETII) (UNII: KRT28P6ITK)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CINNAMON (UNII: 5S29HWU6QB)  
CAPSAICIN (UNII: S07O44R1ZM)  
MYRRH (UNII: JC71GJ1F3L)  
ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)  
CLOVE (UNII: K48IKT5321)  
LYCOPODIUM JAPONICUM TOP (UNII: CI148ZPI0D)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83559-001-011 in 1 BAG; Type 0: Not a Combination Product01/06/2023
2NDC:83559-001-023 in 1 BAG; Type 0: Not a Combination Product01/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01601/06/2023
Labeler - Henan Enokon Medical Instrument Co Ltd. (701730676)
Establishment
NameAddressID/FEIBusiness Operations
Henan Enokon Medical Instrument Co Ltd.701730676manufacture(83559-001)

Revised: 6/2023
Document Id: ff3d50a2-7843-a64e-e053-6294a90a6ead
Set id: ff3d50a2-7842-a64e-e053-6294a90a6ead
Version: 1
Effective Time: 20230628
 
Henan Enokon Medical Instrument Co Ltd.