Label: EARWAX REMOVAL KIT- carbamide peroxide liquid

  • NDC Code(s): 41250-835-33
  • Packager: Meijer Distribution Inc.
  • 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 13, 2019

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  • Drug facts


  • Active ingredient

    Carbamide peroxide 6.5%

    Purpose

    Earwax removal aid

  • Uses

    for occasional use as an aid to soften, looser, and remove excessive earwax

  • Warnings

    For use in the ear only

    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 ear drum
    • 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 4 days
    • Excessive earwax remains after use of this product

    Keep out of 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 and 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 titled or placing cotton in the ear
    • Use twice daily for up to 4 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

    • Avoid exposing bottle to excessive heat and direct sunlight
    • Store bottle in the outer carton
    • Keep cap on bottle when not in use
    • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound
    • Do not use if tamper-evident safety seal is broken or missing
  • Inactive ingredients

    anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

  • Questions?

    1-800-328-5890

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

    Dist. By Meijer Distribution, Inc.  Grand Rapids, MI 49544  www.meijer.com

  • PRINCIPAL DISPLAY PANEL

    Meijer   Washer Bulb Included  Earwax Removal Kit Carbamide Peroxide 6.5%  Earwax Removal Aid  Safe and Effective  0.5 FL OZ (15 mL)

  • Product Labels

    Earwax removal kit

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL KIT 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-835
    Route of AdministrationTOPICAL
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-835-331 in 1 CARTON11/27/2014
    115 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34411/27/2014
    Labeler - Meijer Distribution Inc. (006959555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell Pharmaceuticals, Inc.140653770manufacture(41250-835)
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