FDA.reportPublic FDA data

Murine Ear Wax Removal Drops

Manufacturer
A-S Medication Solutions
Effective date
2020-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:22

Label at a glance#

ProductMurine Ear Wax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure11 sections

Indications and uses

For occasional use as an aid to soften, loosen and remove excessive ear wax

Dosage and administration

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 treatme...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen and remove excessive ear wax

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

this product for more than 4 days

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

alcohol, citric acid, glycerin, polysorbate 20, sodium citrate, tartaric acid

Questions? 1-877-854-0853

OTC - QUESTIONS SECTION

Murine.com

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-3895

NDC: 50090-3895-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Carbamide peroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3895-02023-01-30C16284748780-1f386c649-a886-0266-e053-dadaa90a7c1aMurine Ear Wax Removal Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3895-0Murine EarWax Removal Drops1 in 1 CARTONLIQUID13
50090-3895-0Murine EarWax Removal Drops15 mL in 1 BOTTLE, DROPPERLIQUID153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3895MURINE EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200122_c91f328f-c9d7-48ce-8453-fa47adc53262.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-389550090-3895-0
0295-7362

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TARTARIC ACIDW4888I119HIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a488ed1b-4775-4bdd-9a37-13841e2206e6c91f328f-c9d7-48ce-8453-fa47adc532622020-01-18WarningsExact identifier
spl id: a488ed1b-4775-4bdd-9a37-13841e2206e6
spl set id: c91f328f-c9d7-48ce-8453-fa47adc53262

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.