EAR DRY LEADER (ISOPROPYL ALCOHOL, GLYCERIN) LIQUID [CARDINAL HEALTH]

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EAR DRY LEADER (ISOPROPYL ALCOHOL, GLYCERIN) LIQUID [CARDINAL HEALTH]
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NDC 37205-619-01
Set ID 53cd5182-c697-4833-a88e-b443c9f4b026
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART344
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  • ACTIVE INGREDIENT

    Isopropyl Alcohol 94.998%, Glycerin 5.0%

  • INDICATIONS & USAGE

    Uses

    Helps relieves the discomfort of water-clogged ears by drying excess water due to water activities.

  • WARNINGS

    Warnings

    Do not use: if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor.  If you have an injury or perforation (hole) of the ear drum of after ear surgery unless directed by a doctor.  Avoid contact with eyes.  If accidental contact occurs, flush eyes with water and consult a doctor. Discontinue use and consult a doctor if:  undue irritation or sensitivity occurs.

  • DOSAGE & ADMINISTRATION

    Directions

    FOR USE IN THE EAR ONLY.  To use:  remove cap, apply 4-5 drops in each ear after exposing ears to water such as swimming, showering or bathing or as directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Juice, Chamomile Recutita (Matricaria) Flower Oil.

  • PURPOSE

    Purpose

    Helps dry and relieve water-clogged ears.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • Questions? 1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EAR DRY  LEADER
    isopropyl alcohol, glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-619
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol94.998 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    Chamomile (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-619-011 in 1 CARTON12/01/2011
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34412/01/2011
    Labeler - Cardinal Health (097537435)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(37205-619) , label(37205-619)
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