Label: ALLURE ICE COLD ANALGESIC- menthol and camphor gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 27, 2012

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  • Active Ingredients

    Menthol             1.0%

    Camphor            0.5%

  • Purpose

    Topical Analgesic

  • Uses

    for the temporary relief  of minor aches and pains in muscles and joints associated with
    • simple backache
    • strains
    • sprains
    • sports injuries
    • arthritis
    • bruises

  • Warnings

    For external use only

    Do not use
    • with other topical pain relievers
    • with heating pads or heating devices
  • When using this product

    • do not use in or near eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • Stop use and ask doctor if

    • condition worsens
    • symptoms last more than 7 days or clean up and occur again within a few days
    • redness or irritation develops
  • If pregnant or breast-feeding,

    • ask a health professional before use
  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    • clean affected area before applying product
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

  • Inactive ingredient

    benzyl alcohol, butylated hydroxytoluene, carbopol, colour brillient blue, creasmer RH 40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water and sodium hydroxide
  • PRINCIPAL DISPLAY PANEL

    ALLURE ICE COLD GEL
    ANALGESIC GEL
    8 FL.OZ (226 GRAM)
    PRINCIPAL DISPLAY PANEL



  • INGREDIENTS AND APPEARANCE
    ALLURE ICE COLD ANALGESIC 
    menthol and camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER 934 (UNII: Z135WT9208)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-004-17127 g in 1 TUBE
    2NDC:52000-004-18170 g in 1 TUBE
    3NDC:52000-004-13170 g in 1 BOTTLE, PLASTIC
    4NDC:52000-004-14226 g in 1 BOTTLE, PLASTIC
    5NDC:52000-004-15300 g in 1 BOTTLE, PLASTIC
    6NDC:52000-004-16500 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2012
    Labeler - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-004)
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