EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS]

EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS]
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NDC 69842-040-01, 69842-041-07
Set ID 5a910721-4b33-42f0-b35c-7eea8f7d1898
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART344
  • ACTIVE INGREDIENT

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

  • PURPOSE

  • Uses

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

  • WARNINGS

    Warnings
    Ask a doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in the ear • dizziness• an injury or perforation (hole) of the eardrum • recently had ear surgery
    When using this product avoid contact with the eyes

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • SPL UNCLASSIFIED SECTION

  • DOSAGE & ADMINISTRATION

    Directions
    FOR USE IN THE EAR ONLY
    adults and children over 12 years of age:
    • tilt head sideways • 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 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: consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EARWAX REM  CVS
    carbamide peroxide 6.50% kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-041
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-041-071 in 1 KIT05/14/2010
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    EARWAX REM  CVS
    carbamide peroxide solution/ drops
    Product Information
    Item Code (Source)NDC:69842-040
    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:69842-040-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/14/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/14/2010
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-040) , label(69842-040) , pack(69842-041)

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