Otix Ear Wax Removal System, Ear Wax & Bulb

Otix Ear Wax Removal System, Ear Wax & Bulb
SPL v2
SPL
SPL Set ID 15868798-28cd-4495-9baf-711e81ad8bdd
Route
AURICULAR (OTIC)
Published
Effective Date 2022-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Sodium Citrate Sodium Lauryl Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-01
Description

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Medication Information

Purpose

Earwax removal aid

Description

Carbamide peroxide 6.5%

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Warnings

For use in the ear only

Directions

FOR USE IN THE EAR ONLY

Adults and children over 12 years of age:

  • Tilt head sideways and place 5 to 10 drops into ear
  • 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: consult a doctor
Questions?

1-800-328-5890

Active Ingredient

Carbamide peroxide 6.5%

Other Information
  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap in bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an assoiciated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing
Package Labeling:

Inactive Ingredients
  • anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water
When Using This Product
  • avoid contact with the eyes
Stop Use and Ask A Doctor If
  • you need to use for more than 4 days
  • excessive earwax remains after use of this product
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 ear drum
  • recently had ear surgery

Structured Label Content

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Purpose

Earwax removal aid

Warnings

For use in the ear only

Directions

FOR USE IN THE EAR ONLY

Adults and children over 12 years of age:

  • Tilt head sideways and place 5 to 10 drops into ear
  • 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: consult a doctor
Questions?

1-800-328-5890

Active Ingredient (Active ingredient)

Carbamide peroxide 6.5%

Other Information (Other information)
  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap in bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an assoiciated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing
Package Labeling:

Inactive Ingredients (Inactive ingredients)
  • anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water
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 4 days
  • excessive earwax remains after use of 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 right away.

Ask A Doctor Before Use If You Have (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 ear drum
  • recently had ear surgery

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.974629 · Updated: 2026-03-14T23:02:09.430554