Label: DEBROX- carbamide peroxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • 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 (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
    • 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

  • HOW SUPPLIED

    Product: 50090-4201

    NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

  • Carbamide Peroxide

    Label Image
  • INGREDIENTS AND APPEARANCE
    DEBROX 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4201(NDC:63029-321)
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 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:50090-4201-01 in 1 CARTON03/19/2019
    115 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 - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4201)
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