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Ear Wax Remover (Major Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE, DISPENSING in 1 CARTON (0904-6004-35) > 15 mL in 1 BOTTLE, DISPENSING Label Information

Complete Ear Wax Remover Information

  • Active Ingredient



    Active ingredient                                    Purpose


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



  • Uses



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

  • 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.

  • Indications and Usage


    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 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. If accidental contact with the eyes occurs, flush eyes with water and consult your doctor.

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

    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.
    - when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal

    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
    - lot no. & exp date: see label, bottom of container or box
    - retain carton for future reference on full labeling
    - 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)
  • Inactive Ingredients



    Inactive ingredients

    anhydrous glycerin, citric acid, propylene glycol, sodium lauryl sulfate, sodium citrate, tartaric acid
  • Principal Display Panel

    NDC 0904-6004-35

    EAR WAX REMOVER
    WITH IRRIGATOR
    Earwax Removal Aid
    (carbamide peroxide 6.5%)

    Distributed by:

    MAJOR PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150  USA

    Ear Wax Remover


  • Questions?

     Adverse Drug Event Call toll free: (800) 616-2471


  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVER 
    carbamide peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6004
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 65 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERYL 1-DIACETYLTARTARATE 2,3-STEARATE (UNII: M25488413L)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6004-35 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 05/27/2009
    Labeler - Major Pharmaceuticals (191427277)