Label: BLUE ICE- 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 30, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Menthol 2.0%

  • PURPOSE

    Purpose
    External pain reliever

  • INDICATIONS & USAGE

    Uses
    Temporary relief of minor pains of muscles and joints associated with

    • Simple back ache
    • Arthritis
    • Sprains, strains or bruises
  • WARNINGS

    Warning
    For external use only. Avoid contact with eyes

  • DO NOT USE

    Do not use

    • Internally
    • With heating pads or devices
    • On wounds or damaged skin
  • ASK DOCTOR

    Ask doctor before use if you have sensitive skin

  • WHEN USING

    When using this product
    • Use only as directed
    • Do not bandage tightly
    • Avoid contact with eyes and mucus membranes
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately
  • INDICATIONS & USAGE

    Direction
    • Adult and children 2 years of age and older. Clean skin thoroughly. Apply liberally to affected area not more than 3-4 times daily. No protective cover needed.
    • May be used with ice packs
    • May be used with wet or dry bandage, but wrap loosely
    • Children under 2 years of age, consult a doctor
  • SPL UNCLASSIFIED SECTION

    Other Information store between 59-85F (15-30C)
    • Keep tightly closed
    • Do not use, pour, spill or store near heat or open flames
  • INACTIVE INGREDIENT

    Other Ingredients Carbomer 940, FDC Blue No. 1, Isopropyl Alcohol, Propylene Glycol, Purified Water, Sodium Hydroxide,

  • PRINCIPAL DISPLAY PANEL

    Package Label

    image of package label

  • INGREDIENTS AND APPEARANCE
    BLUE ICE  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51444-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51444-002-76216 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2010
    Labeler - JMD All Star Impex Inc (962316662)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steller Mercantile Pvt.Ltd.650493005manufacture
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