QUALITY CHOICE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION, INC.]

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  • QUALITY CHOICE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION, INC.]

QUALITY CHOICE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION, INC.]
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NDC 63868-027-16
Set ID d8fd8102-114f-415d-9083-f98a63f9d1b3
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association, Inc.
Generic Name
Product Class
Product Number
Application Number PART344
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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.

    Distributed by C.D.M.A., Inc.  43157 W. Nine Mile Novi, MI 48376-0995  www.qualitychoice.com  Questions: 248-449-9300

  • PRINCIPAL DISPLAY PANEL

    Quality Choice Earwax Removal Drops Earwax Removal Aid  Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating   0.5 FL OZ (15mL)

  • Product Labels

    image description

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE EARWAX REMOVAL DROPS 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-027
    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:63868-027-161 in 1 CARTON11/27/2014
    115 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34411/27/2014
    Labeler - Chain Drug Marketing Association, Inc. (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell Pharmaceuticals, Inc.140653770manufacture(63868-027)
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