EAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]

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EAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]
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NDC 49035-552-01, 49035-554-07
Set ID ea835ce6-4413-4bf3-8ce8-89a3489a7dbf
Category HUMAN OTC DRUG LABEL
Packager Walmart
Generic Name
Product Class
Product Number
Application Number PART344
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  • Active ingredient                              Purpose

    Carbamide Peroxide - 6.50%             Earwax removal aid

  • INDICATIONS & USAGE

  • PURPOSE

    ​Uses​ for occasional use as an aid to soften, loosen and remove excessive ear wax

  • Warnings For external use only

    Keep out of reach of the children

    If product is 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 tilted 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 of age: consult a doctor.

    Other information

    • Protect from heat and direct sunlight • Keep cup on bottle when not in use

    Inactive ingredient

    Aloe Barbadensis Leaf Extract
    Chamomilla Recutita (Matricaria) Flower Extract
    Glycerin
    Mineral Oil
    Oxyquinoline Sulfate
    Water

    Questions or comments?
    1-866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL SYSTEM 
    carbamide peroxide - 6.50% kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-554
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-554-071 in 1 KIT08/15/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    EAR WAX REMOVAL DROPS   WELL AT WALGREENS
    carbamide peroxide - 6.50% solution/ drops
    Product Information
    Item Code (Source)NDC:49035-552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-552-0115 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34408/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/04/2011
    Labeler - Walmart (051957769)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(49035-552) , pack(49035-554)
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