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Ear Wax Removal Aid (Continental Manufacturing Chemist, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 15 mL in 1 BOTTLE, DROPPER (49794-003-15) Label Information

Complete Ear Wax Removal Aid Information

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: For use in the ear only. For use by 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 ear.  Use twice daily for up to 4 days, if needed or as directed by a physician.  Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  For children under 12 years of age, consult a physician.  NOTE: When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.


  • WARNINGS

    WARNINGS:  DO NOT USE if you have ear drainage or discharge, ear pain, irritation, or rash in the ear, or if you are dizzy; consult a physician.  DO NOT USE if you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a physician.  DO NOT USE for more than 4 days; if excessive earwax remains after use of this product, consult a physician.  Avoid contact with eyes.  If swallowed, get medical help or contact a Poison Control Center right away.


  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Carbamide Peroxide 6.5%


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN


  • PURPOSE

    Softens and removes excessive earwax safely and gently.


  • INACTIVE INGREDIENT

    Inactive Ingredient: anhydrous glycerin


  • INDICATIONS & USAGE

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


  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL AID 
    carbamide peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49794-003
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    carbamide peroxide (UNII: 31PZ2VAU81) (carbamide peroxide - UNII:31PZ2VAU81) carbamide peroxide 6.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    glycerin (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49794-003-15 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part344 08/27/2010
    Labeler - Continental Manufacturing Chemist, Inc. (005278007)
    Establishment
    Name Address ID/FEI Business Operations
    Continental Manufacturing Chemist, Inc. 005278007 manufacture