Label: EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE- 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 03/13

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  • ACTIVE INGREDIENT

    Active Ingredient

    Carbamide Peroxide 6.5%

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  • PURPOSE

    Purpose

    Softens and Loosens Wax

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  • INDICATIONS & USAGE

    Uses

    Safely and gently removes ear wax.

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  • WARNINGS

    Warnings

    Do not use: if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor.  If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor.  For more than four consecutive days.

    When using this product: avoid contact with the eyes.

    Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.

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

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  • DOSAGE & ADMINISTRATION

    Directions

    FOR USE IN THE EAR ONLY.  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 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 of age:  consult a doctor.

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  • INACTIVE INGREDIENT

    Inactive ingredients

    Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil

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  • PRINCIPAL DISPLAY PANEL

    Ear Wax Removal System

    Carton label



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  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVING DROPS  CARBAMIDE PEROXIDE
    preferred plus liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61715-031
    Route of Administration AURICULAR (OTIC) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Carbamide Peroxide (HYDROGEN PEROXIDE) Carbamide Peroxide 6.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    OXYQUINOLINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-031-74 1 in 1 CARTON
    1 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part344 03/15/2013
    Labeler - Kinray Inc (012574513)
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