Label: EAR DRY LEADER- isopropyl alcohol, glycerin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 8, 2018

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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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