FAMILY CARE BACK PAIN THERAPY (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM OLEORESIN ) PATCH [UNITED EXCHANGE CORP]

FAMILY CARE BACK PAIN THERAPY (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM OLEORESIN ) PATCH [UNITED EXCHANGE CORP]
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NDC 65923-901-37
Set ID e3f69b3d-9376-41d6-bc63-a0f5ffc4ad91
Category HUMAN OTC DRUG LABEL
Packager UNITED EXCHANGE CORP
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Camphor 80mg / patchTopical Analgesic
    Menthol 24mg / patchTopical Analgesic
    Capsicum Extract 16mg / patchTopical Analgesic
  • PURPOSE

    Uses

    For temporary relief of pains.

  • WARNINGS

    Warnings

    FOR EXTERNAL USE ONLY

  • WHEN USING

    When using this product
    • Use only as directed
    • 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 30 minutes after bathing
  • STOP USE

    Stop use and ask a doctor if
    • Condition worsens
    • Severe skin irritation occurs
    • Pain persists for more than 7 days
  • PREGNANCY OR BREAST FEEDING


    If pregnant or breast-feeding, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.
    If swallowed, get medical help or contact Poison Control Center right away.
  • INDICATIONS & USAGE

    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
  • STORAGE AND HANDLING

    Other Information

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aluminium glycinate, eucalyptus oil, glycerin, kaolin, mentha oil, polysorbate 80, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, polyacrylic acid solution, sorbitol solution, hydrotalcite, water

  • DOSAGE & ADMINISTRATION

    Distributed By:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703


    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE BACK PAIN THERAPY 
    camphor (synthetic), menthol, and capsicum oleoresin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)80 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24 mg
    CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSICUM OLEORESIN16 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-901-371 in 1 BOX
    12 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/27/2011
    Labeler - UNITED EXCHANGE CORP (840130579)

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