SPL v2
SPL
SPL Set ID dda4c4bf-425e-4fff-e053-2a95a90a51bc
Route
TOPICAL
Published
Effective Date 2022-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (6.5 g)
Inactive Ingredients
Citric Acid Monohydrate Propylene Glycol Tartaric Acid Sodium Lauryl Sulfate Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-27
Description

Carbamide Peroxide 6.5%

Medication Information

Warnings and Precautions

Do not use

  • if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor
  • if you have an injury or perforation (hole) of the eardrum or after ear surgery unless directed by a doctor
  • for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

When using this product avoid contact with the eyes. If accidental contact with the eyes occurs, flush your eyes with water and consult a doctor.

Indications and Usage

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

Dosage and Administration

FOR IN EAR USE 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 of age: consult a doctor.

Description

Carbamide Peroxide 6.5%

Section 50565-1

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

Section 51727-6

Citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid.

Section 51945-4

Section 55105-1

Earwax removal aid

Section 55106-9

Carbamide Peroxide 6.5%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

FOR IN EAR USE 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 of age: consult a doctor.

Warnings and Precautions (34071-1)

Do not use

  • if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor
  • if you have an injury or perforation (hole) of the eardrum or after ear surgery unless directed by a doctor
  • for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

When using this product avoid contact with the eyes. If accidental contact with the eyes occurs, flush your eyes with water and consult a doctor.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Earwax removal aid

Section 55106-9 (55106-9)

Carbamide Peroxide 6.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:50.571470 · Updated: 2026-03-14T23:05:54.616139