Label: CVS EARWAX REMOVAL AID - carbamide peroxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/11

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  • ACTIVE INGREDIENT



    Active ingredient                                 Purpose


    Carbamide Peroxide 6.5%..........................Earwax Removal Aid


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  • PURPOSE



    Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
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  • 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.
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  • INDICATIONS & USAGE


    Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
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  • 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 ear drum
    - recently had ear surgery

    Stop use and ask a doctor if

    - you need to use for more than four days
    - excessive wax remains after use of this product

    When using this product - avoid contact with the eyes

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away Close
  • DOSAGE & ADMINISTRATION



    Directions
    FOR USE IN THE EAR ONLY

    Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.

    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 ear syringe.

    Children under 12 years of age: consult a doctor.

    Other information
    - avoid exposing the bottle to excessive heat and direct sunlight
    - keep cap on bottle when not in use
    - Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound
    - Note: Oversize packaging for ease in reading label information. Contains one bottle.
    - Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
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  • INACTIVE INGREDIENT



    Inactive ingredients

    glycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, citric acid, flavor, sodium stannate
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  • INGREDIENTS AND APPEARANCE
    CVS EARWAX REMOVAL AID 
    carbamide peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-257
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CARBAMIDE PEROXIDE (CARBAMIDE PEROXIDE) CARBAMIDE PEROXIDE 65 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    SODIUM LAUROYL SARCOSINATE  
    SODIUM STANNATE  
    PROPYLENE GLYCOL  
    CITRIC ACID MONOHYDRATE  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (FLAVOR) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-257-27 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part344 04/25/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    Name Address ID/FEI Business Operations
    Pharma Pac, LLC 140807475 manufacture
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