Label: EAR WAX REMOVAL AID- carbamide peroxide liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 17, 2011

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49794-003
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carbamide peroxide (UNII: 31PZ2VAU81) (carbamide peroxide - UNII:31PZ2VAU81) carbamide peroxide6.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49794-003-1515 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34408/27/2010
    Labeler - Continental Manufacturing Chemist, Inc. (005278007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Continental Manufacturing Chemist, Inc.005278007manufacture
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