Label: COLD SPOT POINT RELIEF- menthol ointment

  • 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 October 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients: Menthol

  • INACTIVE INGREDIENT

    Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed consult physician

  • WARNINGS

    Warnings Section: For external use only, avoid contact with eyes, do not apply to open wounds or damaged skin, if symptoms persist for more than seven days discontinue use and consult physician, keep out of reach of children and if swallowed consult physician, do not bandage tightly.

  • PURPOSE

    pain relief

  • INDICATIONS & USAGE

    Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.



     
  • DOSAGE & ADMINISTRATION

    Apply directly to effected area. Do not use more than four times per day.

  • PRINCIPAL DISPLAY PANEL

    ColdSpot Point Relief Pain Relieving spray, all natural ingredients.
    carton image
  • INGREDIENTS AND APPEARANCE
    COLD SPOT  POINT RELIEF
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL13 mL  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA CORDIFOLIA FLOWER (UNII: JCG1OSZ7A8)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    peppermint oil (UNII: AV092KU4JH)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-002-0390 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/24/2010
    Labeler - Fabrication Enterprises (070577218)
    Registrant - Fabrication Enterprises (070577218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fabrication Enterprises070577218relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    pure source969241041manufacture
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