OTC Medication Information: Murine Ear Wax Removal Drops

MURINE EAR WAX REMOVAL DROPS- carbamide peroxide liquid
Prestige Brands Holdings, Inc.

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 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

PRINCIPAL DISPLAY PANEL

Murine Ear Wax Removal Drops
Carbamide Peroxide / Ear Wax Removal Aid
0.5 FL OZ (15 mL)

Murine Ear Wax Removal Drops
Carbamide Peroxide / Ear Wax Removal Aid
0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL

Murine Ear Wax Removal System
Carbamide Peroxide / Ear Wax Removal Aid
0.5 FL OZ (15 mL) & SYRINGE

Murine Ear Wax Removal System
Carbamide Peroxide / Ear Wax Removal Aid
0.5 FL OZ (15 mL) & SYRINGE

MURINE EAR WAX REMOVAL DROPS
carbamide peroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-361
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE 65 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERIN
POLYSORBATE 20
SODIUM CITRATE
TARTARIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67172-361-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (67172-361-01)
2 NDC:67172-361-02 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (67172-361-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part344 06/01/2012
Labeler — Prestige Brands Holdings, Inc. (159655021)

Revised: 10/2019 Prestige Brands Holdings, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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