EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [PREMIER VALUE]

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  • EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [PREMIER VALUE]

EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [PREMIER VALUE]
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NDC 68016-271-01
Set ID a9c14337-607d-4951-b349-fd6cac29bb27
Category HUMAN OTC DRUG LABEL
Packager Premier Value
Generic Name
Product Class
Product Number
Application Number PART344
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  • Active ingredient                        Purpose

    Carbamide peroxide  6.5%          Earwax removal aid

  • PURPOSE

  • INDICATIONS & USAGE

    For occasional use as an aid to soften, loosen and remove excessive earwax

  • Warnings


    Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

    When using this product avoid contact with eyes

    Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product

    Keep out of reach of the children
    If product is swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    DirectionsFor 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.

  • INACTIVE INGREDIENT

    Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

  • Questions?866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL DROPS 
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-271
    Route of AdministrationAURICULAR (OTIC)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
    Sodium Stannate (UNII: NJ7C1V83KG)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-271-011 in 1 CARTON05/12/2014
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/12/2014
    Labeler - Premier Value (101668460)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(68016-271) , label(68016-271)
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