MURINE EAR WAX REMOVAL DROPS- carbamide peroxide liquid 
Denison Pharmaceuticals, 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.

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Murine Ear Wax Removal Drops

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)

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 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 (UNII: 1Q73Q2JULR)  
TARTARIC ACID (UNII: W4888I119H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-7362-021 in 1 CARTON06/01/2012
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 - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208manufacture(0295-7362)

Revised: 1/2019
Document Id: 7fa985c8-3c38-097f-e053-2991aa0a0ac9
Set id: 457b72b7-774c-4a6c-a7be-2b86132fa4cb
Version: 2
Effective Time: 20190117
 
Denison Pharmaceuticals, Inc.