Label: ENOKON PAIN RELIEF PATCH- pain relief patch patch

  • NDC Code(s): 83559-002-01, 83559-002-02
  • Packager: Henan Enokon Medical Instrument Co Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 29, 2023

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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

  • INGREDIENTS AND APPEARANCE
    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)
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