Label: MURINE EAR WAX REMOVAL DROPS- carbamide peroxide liquid

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

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 January 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Carbamide peroxide 6.5%

  • Purpose

    Earwax removal aid

  • Uses

    For occasional use as an aid to soften, loosen and remove excessive ear wax

  • Warnings

    For external use only

    Do not use

    this product for more than 4 days

    Ask a doctor before use

    • if you have ear drainage or discharge, ear pain, irritation, a rash in the ear or are dizzy
    • if you have an injury or perforation (hole) of the eardrum or after ear surgery

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    excessive ear wax remains after 4-day treatment with this product

    Never insert cotton swabs, toothpicks, hairpins or other objects into the ear canal to remove earwax.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

  • Directions

    FOR USE IN THE EAR ONLY. Remove any hearing aids before using this product.

    • Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear canal.

    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 bulb ear syringe. The tip of the ear syringe should not obstruct the flow of fluid leaving the ear.

    Children under 12 years of age: consult a doctor.

  • Other information

    • Murine® Ear Drops foam upon being placed in the ear due to the release of oxygen.
    • This product is not intended to restore hearing loss due to medical reasons. In such cases, consult a doctor.
    • Protect from heat and sunlight. Secure cap tightly on bottle when not in use.
    • Tamper-Evident: Do not use if neckband on bottle is broken or missing.
    • Check expiration date before using.
  • Inactive ingredients

    alcohol, citric acid, glycerin, polysorbate 20, sodium citrate, tartaric acid

  • Questions? 1-877-854-0853

    Murine.com

  • HOW SUPPLIED

    Product: 50090-3895

    NDC: 50090-3895-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

  • Carbamide peroxide

    Label Image
  • INGREDIENTS AND APPEARANCE
    MURINE EAR  WAX REMOVAL DROPS
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3895(NDC:0295-7362)
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3895-01 in 1 CARTON12/04/2018
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34406/01/2012
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3895)
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