LANDER POLAR ICE (MENTHOL) GEL [ABACO PARTNERS LLC DBA SUREFIL]

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LANDER POLAR ICE (MENTHOL) GEL [ABACO PARTNERS LLC DBA SUREFIL]
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NDC 20890-0020-1
Set ID 35abbfe2-39a3-4f24-b23e-84d8614e07e7
Category HUMAN OTC DRUG LABEL
Packager Abaco Partners LLC DBA Surefil
Generic Name
Product Class
Product Number
Application Number PART356
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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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