Murine Ear Wax Removal System_67172-362

Murine Ear Wax Removal System_67172-362
SPL v1
SPL
SPL Set ID 2291fb2b-2daa-40a9-ab36-52a990dc95f4
Route
AURICULAR (OTIC)
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Alcohol Citric Acid Monohydrate Glycerin Polysorbate 20 Sodium Citrate Tartaric Acid

Identifiers & Packaging

Marketing Status
EXPORT ONLY Active Since 2025-10-15

Description

Drug Facts

Purpose

Earwax removal aid


Medication Information

Purpose

Earwax removal aid

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Warnings

For external use only

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.

Do Not Use

this product for more than 4 days

Questions?

1-877-854-0853

Murine.com

Active Ingredient

Carbamide peroxide 6.5%

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

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
Principal Display Panel

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.


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Earwax removal aid

Warnings

For external use only

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.

Do Not Use (Do not use)

this product for more than 4 days

Questions?

1-877-854-0853

Murine.com

Active Ingredient (Active ingredient)

Carbamide peroxide 6.5%

Other Information (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 (Inactive ingredients)

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

Ask A Doctor Before Use (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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (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. (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.


Advanced Ingredient Data


Raw Label Data

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