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

  • NDC Code(s): 83559-001-01, 83559-001-02
  • 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 28, 2023

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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

  • INGREDIENTS AND APPEARANCE
    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)
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