Label: DEBROX- carbamide peroxide liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 1, 2024

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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 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 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 or comments?

    call toll-free 1-866-255-5202   Debrox.com

  • PRINCIPAL DISPLAY PANEL

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

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

    71205-136-15
  • INGREDIENTS AND APPEARANCE
    DEBROX 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-136(NDC:63029-322)
    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:71205-136-151 in 1 CARTON10/01/2018
    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 DrugM01406/01/2012
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-136)
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