Label: DEBROX- carbamide peroxide liquid

  • NDC Code(s): 63029-321-01, 63029-321-02
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 27, 2025

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  • SPL UNCLASSIFIED SECTION

    Debrox Earwax Removal Aid

    Drug Facts

  • Active ingredient

    Carbamide peroxide 6.5% non USP

  • Purpose

    Earwax removal aid

  • Uses

    For occasional use as an aid to soften, loosen, and remove excessive earwax

  • Warnings

    Ask a doctor before use if you have

    ear drainage or discharge • ear pain

    irritation or rash in the ear • dizziness

    an injury or perforation (hole) of the eardrum • recently had ear surgery

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    you need to use for more than four days

    excessive earwax remains after use of this product

  • Keep this and all drugs out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    FOR USE IN THE EAR ONLY

    adults and children over 12 years of age:

    tilt head sideways place 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in ear • use twice daily for up to four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

    children under 12 years: consult a doctor

  • Other information

    • do not store above 25C (77F)
    • store bottle in the outer carton, in an upright position
    • product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
    • keep tip on bottle when not in use
  • Inactive Ingredients

    citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water

  • Questions?

    1-866-255-5202  Debrox.com

  • Principal Display Panel

    Debrox Earwax Removal Aid 0.5 FL OZ (15 mL)

    Debrox Earwax Removal Aid 0.5 FL OZ (15 mL)

  • Principal Display Panel

    Debrox Earwax Removal Kit 0.5 FL OZ (15 mL)

    Debrox Earwax Removal Kit 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    DEBROX 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-321
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-321-011 in 1 CARTON08/01/2012
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:63029-321-021 in 1 CARTON08/01/2012
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01408/01/2012
    Labeler - Medtech Products Inc. (122715688)
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