Label: LEADER EAR DROPS FOR SWIMMERS liquid

  • NDC Code(s): 70000-0478-1
  • Packager: Cardinal Health, 110 dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • ACTIVE INGREDIENT

    Isopropyl Alcohol 95% in 5% Anhydrous Glycerin

  • PURPOSE

    Ear Drying Aid

  • INDICATIONS & USAGE

    Dries water in the ears

  • WARNINGS

    Flammable: Keep away from fire or flame

    Do not use in the eyes

  • DOSAGE & ADMINISTRATION

    Apply 4 to 5 drops in each affected ear

  • WHEN USING

    Store at room temperature

    keep tightly closed

  • INACTIVE INGREDIENT

    Glycerin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. in case of accidental ingestion, seek professional assitance or contact a poison control center immediately. (1-800-222-1222)

  • PRINCIPAL DISPLAY PANEL

    ear

  • INGREDIENTS AND APPEARANCE
    LEADER EAR DROPS FOR SWIMMERS 
    leader ear drops for swimmers liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0478
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL950 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0478-130 mL in 1 CONTAINER; Type 0: Not a Combination Product04/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01404/24/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(70000-0478) , pack(70000-0478) , manufacture(70000-0478) , analysis(70000-0478)
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