Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 239702af-cf93-43ee-b1af-8e53642395c1
Route
TOPICAL
Published
Effective Date 2018-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Glycerin Anhydrous Citric Acid Propylene Glycol Sodium Lauroyl Sarcosinate Sodium Stannate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01
Description

Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications

Medication Information

Description

Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications

Uses

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

Section 55105-1

Earwax removal aid

warnings

Do not use

  • if you are dizzy
  • if you have ear drainage or discharge, ear pain, irritation or rashin the ear. Consult your doctor.
  • if you have an injury or perforation (hole) of the ear drum or after ear surgery, unless directed by a doctor
directions

​FOR USE IN THE EAR ONLY

Remove any hearing aids before use

Adults and children over 12 years and over:

  • Tilt head to the side and place 5 to 10 drops into the 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 earwax 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: Ask a doctor.

Active Ingredient

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

other Information
  • do not store above 25C (77F)
  • store bottle in outer carton
  • product foams on contact with earwax due to the release of oxygen. There may be an associated "crackling" sound
  • Keep cap on bottle when not in use
Questions & Comments?

1-800-540-3765

Principal Display Panel

When Using This Product

avoid contact with the eyes.

inactive Ingredients

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water

Stop Use and Ask A Doctor If
  • you need to use for more than four days
  • excessive earwax remains after a four day treatment with this product
keep Out of the 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 55105-1 (55105-1)

Earwax removal aid

warnings (Warnings)

Do not use

  • if you are dizzy
  • if you have ear drainage or discharge, ear pain, irritation or rashin the ear. Consult your doctor.
  • if you have an injury or perforation (hole) of the ear drum or after ear surgery, unless directed by a doctor
directions (Directions)

​FOR USE IN THE EAR ONLY

Remove any hearing aids before use

Adults and children over 12 years and over:

  • Tilt head to the side and place 5 to 10 drops into the 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 earwax 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: Ask a doctor.

Active Ingredient (Active ingredient)

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

other Information (Other information)
  • do not store above 25C (77F)
  • store bottle in outer carton
  • product foams on contact with earwax due to the release of oxygen. There may be an associated "crackling" sound
  • Keep cap on bottle when not in use
Questions & Comments? (Questions & comments?)

1-800-540-3765

Principal Display Panel

When Using This Product (When using this product)

avoid contact with the eyes.

inactive Ingredients (Inactive ingredients)

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use for more than four days
  • excessive earwax remains after a four day treatment with this product
keep Out of the Reach of Children (Keep out of the reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.678869 · Updated: 2026-03-14T23:11:05.615438