Carbamide Peroxide

Carbamide peroxide may be found in some form under the following brand names:

• Debrox

Carbamide peroxide is part of the drug class:

• Carbamide products

Source of hydrogen peroxide and nascent oxygen; weak topical antibacterial; mild mechanical effervescence.a

Administration

In fixed combinations with glycerin, administer topically as an oral solution or as a rinse; instill into the external ear as an otic solution.a b c d

Oral Topical Administration

Administer commercially available 10 or 15% oral solution as a topical or rinse.a b d Avoid contact with the eyes.a b e Do not swallow.b d Do not dilute.a b e

Apply oral solution with an applicator or cotton swab to the affected area of the mouth after meals and at bedtime.a b d Expectorate in 1–3 minutes.a b d Rinse applicator after use.d

As a mouthwash, apply oral solution to tongue, mix with saliva, swish around in the mouth over affected area for ≥1 minute, then expectorate.a b e

As an adjunct for orthodontics, after brushing, swish oral solution vigorously for 2–3 minutes, then expectorate.a e

As an adjunct for patients unable to practice normal oral hygiene, after meals, swish oral solution vigorously, then expectorate.a e

Do not rinse the mouth or drink for ≥5 minutes.a

Alternatively, for everyday use, apply to toothbrush, cover with toothpaste, brush normally, and expectorate.e

Otic Administration

In fixed combination with glycerin, instill into the external ear as an otic solution.a c Solution will foam on contact with cerumen.c Avoid contact with eyes.a c e

Remove hearing aids before administration of solution.c

Tilt head sideways; do not insert applicator tip into the ear canal.a c

Keep solution in ear canal for at least 15 minutes (maintain tilted head or place cotton in the ear).a c

If cerumen remains after 4 treatment days, remove by gently irrigating the ear canal with warm (body temperature) water using a soft rubber-bulb otic syringe.a c Do not insert syringe tip into ear canal; do not allow tip of syringe to obstruct the flow of water leaving the ear.c

Dosage

Pediatric Patients

Children ≥2 years of age: For direct application, apply several drops of the 10 or 15% solution to the affected area(s) of the mouth up to 4 times daily.a b d e

Children ≥2 years of age: As a rinse, apply 10–20 drops of the 10% solution onto the tongue.a b e

Children ≥12 years of age: Instill 5–10 drops into the external ear canal twice daily as needed for up to 4 consecutive days.a c

Adults

For direct application: Apply several drops of the 10 or 15% solution to the affected area(s) of the mouth up to 4 times daily.a b d e

As a rinse: Apply 10–20 drops of the 10% solution onto the tongue.a b e

As an adjunct for patients unable to practice normal oral hygiene: Use ≥10 drops of the 10% solution after meals.a

As an adjunct for orthodontics: Use ≥10 drops of the 10% solution after brushing.a

Instill 5–10 drops into the external ear canal twice daily as needed for up to 4 consecutive days.a c

Prescribing Limits

Pediatric Patients

Children ≥ 2 years of age: Maximum 7 days for self-medication.a b d

Children ≥12 years of age: Maximum 4 days for self-medication.a c

Adults

Maximum 7 days for self-medication.a b d

Maximum 4 days for self-medication.a c

Special Populations

No special population dosage recommendations at this time.

Storage

Oral Topical

Tight, light-resistant container; protect from heat and direct sunlight.a b d

Otic

Tight, light-resistant container; protect from heat and direct sunlight.a c

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