Label: POLAR FROST COLD- menthol gel

  • 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 May 16, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 4%

  • Purpose

    cooling pain relief

  • Uses

    Provides cooling pain relief of minor aches and pains of muscles and joints associated with simple back-ache, arthritis, strains, bruises and sprains.

  • Warnings

    For external use only

    Do not use on wounds or damaged skin

    When using this product

    • avoid contact with eyes
    • avoid contact with mucous membranes
    • do not bandage

    • If rash or irritation occurs, discontinue use.
    • The application of external heat, such as an electric heating pad, may result in excessive skin irritation or skin burn.
    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    • Keep out of reach of children.
  • Directions

    • Adults and children 2 years of age and older:
    • Apply a thin layer to the affected area.
    • Make a second application in 5 minutes.
    • Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Do not use, consult a doctor.
  • Inactive Ingredients

    Water, Alcohol, Eucalyptus Globulus Leaf Oil, Carbomer, Aloe Barbadensis Extract, Propylene Glycol, Triethanolamine, Methylparaben, Silica, Propylparaben, Cl 42090 (FD&C Blue No. 1)

  • PRINCIPAL DISPLAY PANEL - 150 ml Tube Label

    With Aloe Vera

    POLAR®
    FROST

    Pain Relieving Gel

    Cold Gel

    METTLER ELECTRONICS®
    corp.

    150 ml - 5 oz.

    Principal Display Panel - 150 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    POLAR FROST COLD 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67138-533
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Trolamine (UNII: 9O3K93S3TK)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67138-533-15150 mL in 1 TUBE
    2NDC:67138-533-7575 mL in 1 BOTTLE, WITH APPLICATOR
    3NDC:67138-533-50500 mL in 1 BOTTLE, PUMP
    4NDC:67138-533-055.43 mL in 1 POUCH
    5NDC:67138-533-643785 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34811/11/2002
    Labeler - Mettler Electronics Corp. (008513913)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niva Medical Oy651595779MANUFACTURE(67138-533)
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