Label: LANDER POLAR ICE- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 18, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Menthol, 2.0%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves:

    -
    Minor muscle aches and pains
  • Warnings

    For external use only; avoid contact with eyes

    When using this product, do not;

    -
    heat
    -
    microwave
    -
    add to hot water or any container where heating water may cause splattering and result in burns
    -
    use in eyes or directly on mucous membranes
     
    take by mouth or place in nostrils
    -
    apply to wounds or damaged skin
    -
    bandage skin

    Consult a doctor and discontinue use:

    If condition worsens, persists for more than 1 week or tends to recur.

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center Immediately.

  • Directions

    For the temporary relief of minor muscle aches and pains. See important warnings under "When using this products"

    -
    not for use on children under 2 years of age
    -
    adults & children 2 years & older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.
  • Inactive Ingredients

    FD&C Blue #1, Camphor, Carbomer, Isopropyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Nonoxynol - 9, Propylene Glycol, Sodium Hydroxide, Water.

  • SPL UNCLASSIFIED SECTION

    Polar Ice® is a registered trademark of Grand Brands LLC, Grand
    Rapids, MI 49512 USA

    UPC: 8-14344-0-1123-9

  • PRINCIPAL DISPLAY PANEL - 226g Container

    LANDER®
    America's Health & Beauty Care Company

    POLAR
    ICE
    TOPICAL ANALGESIC GEL

    NET WT. 8 OZ (226g)

    Made in U.S.A.

    PRINCIPAL DISPLAY PANEL - 226g Container
  • INGREDIENTS AND APPEARANCE
    LANDER  POLAR ICE
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20890-0020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Camphor (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Nonoxynol-9 (UNII: 48Q180SH9T)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20890-0020-1226 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35612/01/2010
    Labeler - Abaco Partners LLC DBA Surefil (964809417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceutical Pvt.916837425MANUFACTURE
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