Enokon Pain relief patch by Henan Enokon Medical Instrument Co Ltd. Complete

Enokon Pain relief patch by

Drug Labeling and Warnings

Enokon Pain relief patch by is a Otc medication manufactured, distributed, or labeled by Henan Enokon Medical Instrument Co Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Complete

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

ENOKON PAIN RELIEF PATCH 
pain relief patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83559-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X)	BORNEOL	1 g  in 100

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83559-002-01	1 in 1 BAG; Type 0: Not a Combination Product	06/28/2023
2	NDC: 83559-002-02	3 in 1 BAG; Type 0: Not a Combination Product	06/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/28/2023	09/06/2024

Labeler - Henan Enokon Medical Instrument Co Ltd. (701730676)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Enokon Medical Instrument Co Ltd.		701730676	manufacture(83559-002)

Revised: 9/2024

Document Id: 2172f2f6-8be9-80ec-e063-6294a90a184e

34390-5

Set id: ff416fb0-3c90-4bc9-e053-6394a90a5447

Version: 2

Effective Time: 20240906