FDA Label for Murine Ear Wax Removal Drops
View Indications, Usage & Precautions
Murine Ear Wax Removal Drops Product Label
The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, Inc.. 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.
- 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.
Tip of applicator should not enter ear canal.
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
Principal Display Panel
Murine Ear Wax Removal Drops
Carbamide Peroxide / Ear Wax Removal Aid
0.5 FL OZ (15 mL)
Murine Ear Wax Removal System
Carbamide Peroxide / Ear Wax Removal Aid
0.5 FL OZ (15 mL) & SYRINGE
* Please review the disclaimer below.