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
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 25, 2021

If you are a consumer or patient please visit this version.

  • 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 not finalpart34805/31/2017
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(70000-0260)