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  5. Label Information: Murine Ear Wax Removal Drops

FDA Label for Murine Ear Wax Removal Drops

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS? 1-877-854-0853
    14. HOW SUPPLIED

Murine Ear Wax Removal Drops Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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