Carbamide Peroxide (Monograph)

Brand names: Auralyt, Auro, Clearcanal, Debrox, Gly-Oxide, Murine
Drug class: Anti-infectives, Miscellaneous
ATC class: D02AE01
VA class: OR900
CAS number: 124-43-6

Medically reviewed by Drugs.com on Apr 3, 2024. Written by ASHP.

Introduction

Source of hydrogen peroxide and nascent oxygen; release of oxygen results in mild mechanical effervescence.

Uses for Carbamide Peroxide

Cerumen Removal

Occasional aid to soften, loosen, and remove excessive cerumen (earwax) from external ear canal.

Oral Irritation and Inflammation

Oral debriding agent and oral wound cleanser for topical treatment of canker sores (aphthous ulcers) and minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

Aid in removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

Adjunct to oral hygiene when normal cleansing measures are inadequate or impossible (e.g., total-care geriatric patients) or adjunct to oral hygiene after regular brushing.

Carbamide Peroxide Dosage and Administration

Administration

Otic Administration

Instill into external ear canal as a 6.5% otic solution.

For topical otic use only.

Avoid contact with eyes. If contact with eyes occurs, flush eyes with water and consult clinician.

Remove hearing aids before administering the otic solution.

Tilt head sideways and instill 5–10 drops of otic solution into ear; do not insert applicator tip into ear canal.

Keep solution in ear canal for several minutes by maintaining tilted head or placing cotton or an ear plug in the ear.

Foaming may occur in ear canal and crackling sound may be heard when otic solution contacts earwax and oxygen is released.

Recap otic solution container after each use.

Any earwax remaining after treatment may be removed by gently flushing ear canal with warm water using soft rubber bulb ear syringe.

Oral, Topical Use Only

Apply 10% oral topical solution to mouth only; do not swallow the oral topical solution.

Avoid contact with eyes.

Do not dilute.

Apply oral topical solution directly from bottle onto affected mouth area(s); expectorate after 2–3 minutes.

Alternatively, use oral topical solution as a mouth rinse by placing 10–20 drops onto tongue, mixing the solution with saliva by swishing it around in mouth over affected area(s) for at least 1 minute, and expectorating.

Dosage

Pediatric Patients

Cerumen Removal

Otic

Children ≥12 years of age: Instill 5–10 drops of 6.5% otic solution into external ear canal twice daily for up to 4 days or as directed by clinician. (See Otic Administration under Dosage and Administration.)

Oral Irritation and Inflammation

Oral Topical

Children ≥2 years of age: For direct application, apply several drops of 10% oral topical solution to affected mouth area(s) up to 4 times daily, after meals and at bedtime, or as directed by clinician (dentist or physician). (See Oral, Topical Use Only under Dosage and Administration.)

Children ≥2 years of age: As an oral rinse, apply 10–20 drops of 10% oral topical solution onto tongue up to 4 times daily, after meals and at bedtime, or as directed by clinician. (See Oral, Topical Use Only under Dosage and Administration.)

Adults

Cerumen Removal

Otic

Instill 5–10 drops of 6.5% otic solution into external ear canal twice daily for up to 4 days or as directed by clinician. (See Otic Administration under Dosage and Administration.)

Oral Irritation and Inflammation

Oral Topical

Direct application: Apply several drops of 10% oral topical solution to affected mouth area(s) up to 4 times daily, after meals and at bedtime, or as directed by clinician (dentist or physician). (See Oral, Topical Use Only under Dosage and Administration.)

Oral rinse: Apply 10–20 drops of 10% oral topical solution onto tongue up to 4 times daily, after meals and at bedtime, or as directed by clinician. (See Oral, Topical Use Only under Dosage and Administration.)

Prescribing Limits

Pediatric Patients

Cerumen Removal

Otic

Children ≥12 years of age (6.5% otic solution): Maximum 4 consecutive days for self-medication.

Oral Irritation and Inflammation

Oral Topical

Children ≥2 years of age (10% oral topical solution): Maximum 7 days for self-medication.

Adults

Cerumen Removal

Otic

6.5% otic solution: Maximum 4 consecutive days for self-medication.

Oral Irritation and Inflammation

Oral Topical

10% oral topical solution: Maximum 7 days for self-medication.

Special Populations

No special population dosage recommendations.

Cautions for Carbamide Peroxide

Warnings/Precautions

Otic Use

Do not use otic solution in patients allergic to the preparation.

Not for self-medication if patient has ear drainage or discharge, ear pain, irritation or rash in ear, dizziness, ear injury, eardrum perforation, or has had ear surgery.

Self-medication: Do not use for >4 consecutive days, unless otherwise directed by clinician.

Discontinue use and contact clinician if excessive earwax remains after using otic solution for 4 consecutive days.

Oral Topical Use

Discontinue use and contact clinician (dentist or physician) if swelling, rash, or fever develops or if irritation, pain, or redness in mouth persists or worsens.

Self-medication: Do not use for >7 days, unless otherwise directed by clinician. Discontinue use and contact clinician if sore mouth symptoms do not improve after 7 days of treatment.

Specific Populations

Pregnancy

Otic solution: At least one manufacturer states that pregnant women should consult clinician before using for self-medication.

Lactation

Otic solution: At least one manufacturer states that women who are breast-feeding should consult clinician before using for self-medication.

Pediatric Use

Otic solution: Do not use in children <12 years of age, unless otherwise directed by clinician.

Oral topical solution: Do not use in children <2 years of age, unless otherwise directed by clinician. Use in children 2–12 years of age only if supervised by an adult.

Common Adverse Effects

Otic solution: Ear pruritus.

Drug Interactions

No formal drug interaction studies.

Stability

Storage

Otic

Solution

Room temperature at <25°C or 15–30°C, depending on manufacturer. Protect from excessive heat and direct sunlight.

Oral, Topical Use Only

Solution

<25°C.

Actions

• Exposure of carbamide peroxide to moisture (e.g., on skin, in mouth) slowly releases hydrogen peroxide and oxygen; effervescence from release of oxygen mechanically removes debris from inaccessible regions. Release of oxygen also results in weak antibacterial properties.

• For otic use, penetrates and softens cerumen (earwax) and release of oxygen provides mild mechanical action resulting in loosening of softened cerumen.

• Probably inhibits odor-causing bacteria, resulting in deodorant activity.

Advice to Patients

• Otic solution: Advise patients to contact a clinician before using if they have ear drainage or discharge, ear pain, irritation or rash in ear, dizziness, ear injury, eardrum perforation, or have had ear surgery.

• Otic solution: Importance of not using for >4 consecutive days, unless otherwise directed by a clinician. Importance of discontinuing use and contacting clinician if excessive earwax remains after using otic solution for 4 consecutive days.

• Otic solution: Advise patients not to use cotton swabs, toothpicks, hairpins, or other objects to remove earwax from ear canal.

• Oral topical solution: Advise patients to discontinue use and contact a clinician (dentist or physician) if swelling, rash, or fever develops or if irritation, pain, or redness in mouth persists or worsens.

• Oral topical solution: Importance of not using for >7 days, unless otherwise directed by a clinician.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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