EAR SYSTEM GNP (CARBAMIDE PEROXIDE 6.50%) KIT [AMERISOURCE BERGEN]

EAR SYSTEM GNP (CARBAMIDE PEROXIDE 6.50%) KIT [AMERISOURCE BERGEN]
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NDC 24385-500-01, 24385-501-07
Set ID b326b175-e792-44ed-a68c-9aa587bb717c
Category HUMAN OTC DRUG LABEL
Packager Amerisource Bergen
Generic Name
Product Class
Product Number
Application Number PART344
  • Active ingredient                     Purpose

    Carbamide Peroxide 6.5%        Softens & removes wax

  • PURPOSE

  • Uses

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

  • 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 eardrum or after ear surgery, unless directed by a doctor.
    When using this product avoid contact with eyes

    Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children
    If product is swallowed, get medical help or contact a Poison Control Center right away
    In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

  • DirectionsDirections 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.

  • Inactive ingredients

    Glyceryn, Oxyquinoline

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    EAR SYSTEM  GNP
    carbamide peroxide 6.50% kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-501
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-501-071 in 1 KIT; Type 0: Not a Combination Product10/15/2003
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    WAX REMOVAL SYSTEM 
    carbamide peroxide 6.50% solution/ drops
    Product Information
    Item Code (Source)NDC:24385-500
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-500-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart344
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/15/2003
    Labeler - Amerisource Bergen (007914906)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(24385-500, 24385-501) , label(24385-500, 24385-501)

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