Murine Ear
FDA Label NDC 50090-3895

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Murine Ear (NDC 50090-3895). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

* Please review the disclaimer below.