Label: DEBROX SWIMMERS EAR- isopropyl alcohol 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 December 25, 2019

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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 head or direct sunlight
    • store at room temperature 15-25ºC (59-77ºF)
    • do not use if foil seal imprinted with “SEALED FOR YOUR PROTECTION” under cap is broken or missing
    • keep carton for full drug facts
  • Inactive

    Glycerin

  • Questions?

    1-800-344-7239 debrox.com

  • PRINCIPAL DISPLAY PANEL

    Debrox ® Swimmer’s Ear

    Isopropyl alcohol 95%

    Ear Drying Drops

    1 FL OZ (30 mL)

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

  • INGREDIENTS AND APPEARANCE
    DEBROX SWIMMERS EAR 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-323
    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:63029-323-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34404/01/2019
    Labeler - Medtech Products Inc. (122715688)
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