Label: DEBROX- carbamide peroxide 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 5, 2017

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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

  • Debrox Earwax Removal Aid 0.5 FL OZ (15 mL)

    Debrox Earwax Removal Aid 0.5 FL OZ (15 mL) Carton

  • 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 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:63029-321-011 in 1 CARTON08/01/2012
    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 finalpart34408/01/2012
    Labeler - Medtech Products Inc. (122715688)
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