Label: LEADER ICE BLUE ANALGESIC- menthol, unspecified form gel

  • NDC Code(s): 70000-0260-1
  • Packager: Cardinal Health, 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 2%

  • Purpose

    Topical Analgesic

  • Uses

    ♦
    temporarily relieves minor aches and pains of muscles and joints associated with
    ♦
    simple backache
    ♦
    arthritis
    ♦
    strains
    ♦
    bruises
    ♦
    sprains
    ♦
    provides cooling penetrating relief
  • Warnings

    For external use only

    Do not use

    ♦
    do not use with other topical pain relievers
    ♦
    do not use with heating pads or other heating devices

    When using this product

    ♦
    avoid contact with the eyes
    ♦
    do not bandage tightly
    ♦
    do not apply to wounds or damaged skin

    Stop use and consult a doctor if

    ♦
    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breastfeeding, ask a health professional before use

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

  • 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: do not use, consult a doctor
  • Other information

    ♦
    do not freeze
    ♦
    store at controlled room temperature 20 degrees to 25 degrees C, in a tightly closed container
    ♦
    store in a cool place
    ♦
    do not use, pour, spill or store near heat or open flame
  • Inactive ingredients

    Ammonium Hydroxide, Blue 1, Carbomer, Copper Sulfate, Isopropyl Alcohol, Magnesium Sulfate, Sodium Hydroxide, Thymol, Water.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

    LEADER

    NDC 70000-0260-1

    Ice Blue
    Gel
    Menthol 2.0%

    Pain Relief Gel

    Cooling
    Greaseless

    COMPARE TO
    MINERAL ICE®
    active ingredient*

    100% Money
    Back Guarantee

    NET WT 8 OZ (226.8 g)

    PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label
  • INGREDIENTS AND APPEARANCE
    LEADER ICE BLUE   ANALGESIC
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0260-1226.8 g in 1 JAR; Type 0: Not a Combination Product05/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01705/31/2017
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(70000-0260)
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