Label: CHOICE PERSONAL CARE THERAPUTIC BLUE 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 November 5, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Menthol 2%

  • Purpose

    External pain reliever

  • Uses

    Temporary relief of mirror pains of muscles and joints associated with

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

    For external use only. Avoid contact with eyes

    Do not use

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

    Ask doctor before use

    if you have sensitive skin

    When using this product

    • Use only as directed
    • Do not bandage tightly
    • Avoid contact with eyes and mucus membranes

    If pregnant or breast feeding,

    ask a health professional before use

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a poison Control Center immediately

  • Direction

    • Adult and children 2 years of age and older. Clean skin thoroughly. Apply 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
  • Other Information

    store between 59-85°F (15-30°C)

    • Keep tightly closed
    • Do not use, pour, spill or store near heat or open flames
  • Other ingredients

    • Camphor, Carbomer 940, FD&C Blue #1, Isopropyl alcohol, Propylene Glycol, Purified Water, Sodium Hydroxide.
  • PRINCIPAL DISPLAY PANEL

    CHOICE PERSONAL CARE
    THERAPUTIC BLUE ICE
    PAIN RELIEVING ANALGESIC GEL

    PRINCIPAL DISPLAY PANEL PAIN RELIEVING ANALGESIC GEL

  • INGREDIENTS AND APPEARANCE
    CHOICE PERSONAL CARE THERAPUTIC BLUE ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-3434
    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)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51628-3434-1226 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/15/2010
    Labeler - My Import Inc (195767988)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steller Mercantile Pvt.Ltd.650493005MANUFACTURE
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