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DEBROX (Medtech Products Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE, DROPPER in 1 CARTON (63029-322-01) > 15 mL in 1 BOTTLE, DROPPER Label Information
LIQUID 1 BOTTLE, DROPPER in 1 CARTON (63029-322-02) > 7 mL in 1 BOTTLE, DROPPER Label Information

Complete DEBROX Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Carbamide peroxide 6.5% non USP*

    *pH differs from USP specifications


  • 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 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 the 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 77F (25C)
    • store bottle in the outer carton
    • 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, sodium stannate, water


  • Questions or comments?

    call toll-free 1-866-255-5202 (English/Spanish) weekdays


  • PRINCIPAL DISPLAY PANEL

    Debrox® DROPS
    Carbamide Peroxide 6.5% Non USP*
    Earwax Removal Aid
    Kit includes soft rubber bulb ear syringe and drops
    ½ FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL
Debrox DROPS
Carbamide Peroxide 6.5% Non USP*
Earwax Removal Aid
Kit includes soft rubber bulb ear syringe and drops
½ FL OZ (15mL)


  • INGREDIENTS AND APPEARANCE
    DEBROX 
    carbamide peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-322
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (CARBAMIDE PEROXIDE - UNII:31PZ2VAU81) CARBAMIDE PEROXIDE 0.065 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-322-02 1 in 1 CARTON
    1 7 mL in 1 BOTTLE, DROPPER
    2 NDC:63029-322-01 1 in 1 CARTON
    2 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part344 06/01/2012
    Labeler - Medtech Products Inc. (122715688)