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 October 1, 2019

If you are a consumer or patient please visit this version.

  • 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 finalpart34406/01/2012
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-136)