Label: DEBROX KIDS- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

  • Purpose

    Isopropyl alcohol 95% in an anhydrous glycerin 5% base ....Ear drying aid

  • Use

    dries water in the ears and relieves water-clogged ears after

    • swimming
    • showering
    • bathing
    • washing the hair
  • Warnings

    Flammable: Keep away from fire or flame

    Do not use in the eyes.

    Ask a doctor before use if you have

    • ear drainage or discharge

    • ear pain, irritation or rash in the ear • dizziness

    • recently had ear surgery

    Stop use and ask a doctor if irritation (too much burning) or pain occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison

    Control Center (1-800-222-1222) right away.

  • Directions

    • unscrew cap from bottle
    • remove foil safety seal from bottle
    • affix applicator cap to bottle
    • remove red applicator cap tip
    • apply 4 to 5 drops in each affected ear
  • Other information

    • recap bottle after each use
    • keep away from heat or direct sunlight
    • store at room temperature 15-25ºC (59-77ºF)
  • Inactive

    Glycerin

  • Questions?

    1-800-344-7239 debrox.com

  • PRINCIPAL DISPLAY PANEL

    Debrox ® Kids

    Isopropyl alcohol 95%

    Ear Drying Drops

    1 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL Debrox ® Kids Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL)

  • INGREDIENTS AND APPEARANCE
    DEBROX KIDS 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-325
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL95 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-325-011 in 1 CARTON06/01/2024
    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 DrugM01406/01/2024
    Labeler - Medtech Products Inc. (122715688)
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