EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [PRODUCT QUEST MFG]

EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [PRODUCT QUEST MFG]
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NDC 64048-5118-1
Set ID abfbf016-fda2-44a3-8bd7-be5eb9cd8b99
Category HUMAN OTC DRUG LABEL
Packager Product Quest Mfg
Generic Name
Product Class
Product Number
Application Number PART344
  • ACTIVE INGREDIENT

    Active ingredient                                           Purpose
    Carbamide Peroxide 6.5%............................Earwax removal aid

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings
    Do not use • if you have ear drainage or discharge, ear pain,
    irritation or rash in the ear, or are dizzy; consult a doctor. • if
    you have an injury or perforation (hole) of the ear drum or after
    ear surgery unless directed by a doctor. • for more than four
    consecutive days.
    When using this product • avoid contact with eyes
    Stop use and ask a doctor if • excessive ear wax remains
    after use of this product for four consecutive days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center right away. If accidental contact
    with eyes occurs, flush eyes with water and consult a doctor.

  • DOSAGE & ADMINISTRATION

    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 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 of age: consult a doctor

  • OTHER SAFETY INFORMATION

    Other information

    Protect from heat and direct sunlight.
    Keep cap on bottle when not in use

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • Questions? 866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL DROPS 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5118
    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 (UNII: V5VD430YW9)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Oxyquinoline Sulfate (UNII: 61VUG75Y3P)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64048-5118-11 in 1 CARTON10/05/2011
    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 finalpart34410/05/2011
    Labeler - Product Quest Mfg (927768135)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(64048-5118) , label(64048-5118)

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