Label: FAMILY CARE BACK PAIN THERAPY (camphor- synthetic, menthol, and capsicum oleoresin patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 27, 2011

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  • 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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