Label: UNIVERSAL ICE COLD ANALGESIC- menthol gel

  • NDC Code(s): 52000-105-01
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • Active Ingredients

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relieves  of minor aches and pains in muscles and joints associated with

    • arthritis
    • simple backache
    • strains
    • bruises
    • sports injuries
    • sprains
    • provides cooling penetrating relief

  • 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 the 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
    • children under 2 years of age: ask a doctor
  • Other information

    • store at controlled room temperature 20 to 25oC (68 to 77oF in a tightly closed container
    • do not use, pour, spill or store near heat or open flame
  • Inactive ingredients

    Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

  • PRINCIPAL DISPLAY PANEL

    ICE COLD
    ANALGESIC GEL
    8 FL.OZ (227 GRAM)
    PRINCIPAL DISPLAY PANEL


  • INGREDIENTS AND APPEARANCE
    UNIVERSAL ICE COLD ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    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:52000-105-01227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/25/2020
    Labeler - Universal Distribution Center LLC (019180459)
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