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

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EAR WAX REMOVAL SYSTEM RITE AID (CARBAMIDE PEROXIDE - 6.50%) KIT [RITE AID]
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NDC 11822-1225-7, 11822-1226-1
Set ID 0a7e2ef1-14a0-44b0-a9ca-0db89b8efbc4
Category HUMAN OTC DRUG LABEL
Packager Rite Aid
Generic Name
Product Class
Product Number
Application Number PART344
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  • Active ingredient                              Purpose

    Carbamide Peroxide - 6.50%             Earwax removal aid

  • Uses

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

  • PURPOSE

  • WarningsFor 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

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL SYSTEM  RITE AID
    carbamide peroxide - 6.50% kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1225
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1225-71 in 1 KIT10/07/2011
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    EAR WAX REMOVAL DROPS  RITE AID
    carbamide peroxide - 6.50% solution/ drops
    Product Information
    Item Code (Source)NDC:11822-1226
    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:11822-1226-115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/07/2011
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-1226) , pack(11822-1225)
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