Ear Wax Removal Aid Drops

Ear Wax Removal Aid Drops
SPL v6
SPL
SPL Set ID 3bded237-4d2c-4b38-bedc-267fdc374194
Route
AURICULAR (OTIC)
Published
Effective Date 2025-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Adipic Acid Glycerin Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-13

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

Directions

FOR USE IN THE EAR ONLY.

  • Adults and children over 12 years of age:
  • tilt head sideways
  • 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.

Children under 12 years of age:consult a doctor.

Active Ingredient

Carbamide peroxide 6.5%

Other Information
  • store at room temperature

  • avoid exposing bottle to excessive heat and direct sunlight

  • store bottle in the outer carton

  • product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.

  • keep cap on bottle when not in use
Inactive Ingredients

adipic acid, anhydrous glycerin, polysorbate 80

Ask A Doctor Before Use
  • if you have ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • an injury or perforation (hole) of the eardrum
  • recently had ear surgery
Principal Display Panel

*Compare to the active ingredient in Debrox ®Drops

NDC 21130-793-15

Ear Wax Removal Aid Drops

Carbamide Peroxide 6.5%

Ear Wax Removal Aid

  • Safe & Gentle
  • Microfoam Cleansing Action
  • Easy to use Instructions

NET WT 0.5 FL OZ (15 mL)

TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

IMPORTANT:Keep this carton for future labeling.

*This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox ®Drops.

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If
  • you need to use for more than four days
  • excessive ear wax remains after use this product
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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

Directions

FOR USE IN THE EAR ONLY.

  • Adults and children over 12 years of age:
  • tilt head sideways
  • 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.

Children under 12 years of age:consult a doctor.

Active Ingredient (Active ingredient)

Carbamide peroxide 6.5%

Other Information (Other information)
  • store at room temperature

  • avoid exposing bottle to excessive heat and direct sunlight

  • store bottle in the outer carton

  • product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.

  • keep cap on bottle when not in use
Inactive Ingredients (Inactive ingredients)

adipic acid, anhydrous glycerin, polysorbate 80

Ask A Doctor Before Use (Ask a doctor before use)
  • if you have ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • an injury or perforation (hole) of the eardrum
  • recently had ear surgery
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

*Compare to the active ingredient in Debrox ®Drops

NDC 21130-793-15

Ear Wax Removal Aid Drops

Carbamide Peroxide 6.5%

Ear Wax Removal Aid

  • Safe & Gentle
  • Microfoam Cleansing Action
  • Easy to use Instructions

NET WT 0.5 FL OZ (15 mL)

TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

IMPORTANT:Keep this carton for future labeling.

*This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox ®Drops.

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)
  • you need to use for more than four days
  • excessive ear wax remains after use this product
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.


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