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Ice Cold Analgesic Gel (Universal Distribution Center LLC)

Available Formats

Dosage Form Package Information Links
GEL 500 g in 1 BOTTLE, PLASTIC (52000-013-16) Label Information
GEL 127 g in 1 TUBE (52000-013-17) Label Information
GEL 170 g in 1 TUBE (52000-013-18) Label Information
GEL 170 g in 1 BOTTLE, PLASTIC (52000-013-13) Label Information
GEL 227 g in 1 BOTTLE, PLASTIC (52000-013-14) Label Information
GEL 300 g in 1 BOTTLE, PLASTIC (52000-013-15) Label Information

Complete Ice Cold Analgesic Gel Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol             1.0%

    Camphor            0.5%


  • PURPOSE

    Purpose

    Topical Analgesic


  • INDICATIONS & USAGE

    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

    Warnings

    For external use only


  • DO NOT USE

    Do not use

    • with other topical pain relievers
    • with heating pads or heating devices


  • WHEN USING

    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

    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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

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


  • DOSAGE & ADMINISTRATION

    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

    Inactive ingredients

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


  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    ICE COLD ANALGESIC GEL

    Topical Analgesic
    NET WT.8 OZ (227g)


  • INGREDIENTS AND APPEARANCE
    ICE COLD ANALGESIC GEL 
    menthol and camphor gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-013
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52000-013-17 127 g in 1 TUBE
    2 NDC:52000-013-18 170 g in 1 TUBE
    3 NDC:52000-013-13 170 g in 1 BOTTLE, PLASTIC
    4 NDC:52000-013-14 227 g in 1 BOTTLE, PLASTIC
    5 NDC:52000-013-15 300 g in 1 BOTTLE, PLASTIC
    6 NDC:52000-013-16 500 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/15/2013
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    Name Address ID/FEI Business Operations
    Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-013)