Label: PAIN RELIEF PATCH patch

  • NDC Code(s): 83559-005-01
  • Packager: Henan Enokon Medical Instrument Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Camphor 80mg
    Menthol 24mg
    Capsicum Extract 16mg

  • Purpose

    Topical analgesic

  • Use

    For temporary relief of pains

  • Warnings

    For external use only

  • Do not use

    ·Do not get into eyes or on mucous membranes
    ·Do not apply to wounds, damaged or irritated skin
    ·Do not bandage or cover with any type of wrap except clothing
    ·Do not use with a heating pad or apply external heat
    ·Do not use 1 hour prior to bathing or within 30 minutes after bathing

  • When Using

    ·Use only as directed

  • Stop Use

    ·Condition worsens
    ·Severe skin irritation occurs
    ·Pain persists for more than 7 days
    ·Symptoms clear up and occur again within a few days

  • Ask Doctor

    If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.
    Children under 12 years, consult doctor before use

  • Keep Out Of Reach Of Children

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    ·Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
    ·Children under 12 years, consult doctor before use
    How to apply:
    ·Clean and dry affected area
    ·Cut open pouch and remove patch
    ·Remove protective film and apply directly to area of pain
    ·Apply to affected area not more than 3 times daily
    ·Wash hands with soap after applying patch
    ·Reseal pouch containing unused patches

  • Other information

    This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.

  • Inactive ingredients

    Aluminum Glycinate, Ethylhexylglycerin, Eucalyptus Oil, Glycerin, Kaolin, Mentha Oil, Phenoxyethanol, Polyvinylpyrrolidone,Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol Solution, Tartaric Acid, Water

  • Questions

    1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    1324

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PATCH 
    pain relief patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83559-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)80 mg  in 100 
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM16 mg  in 100 
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24 mg  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POVIDONE (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83559-005-015 in 1 BOX; Type 0: Not a Combination Product04/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/07/2024
    Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Enokon Medical Instrument Co., Ltd.701730676manufacture(83559-005)