Carbamide peroxide is a source of hydrogen peroxide and nascent oxygen; the effervescence caused by the release of oxygen mechanically removes debris from inaccessible regions.
Carbamide peroxide otic solution is used as an occasional aid to soften, loosen, and remove excessive cerumen (earwax) from the external ear canal.1, 2, 3, 4, 5, 6 Glycerin, present in the otic solution, penetrates and softens cerumen and the release of oxygen from carbamide peroxide provides a mild mechanical action resulting in loosening of the softened cerumen. Irrigation with warm water may be necessary to remove the loosened cerumen.
Oral Irritation and Inflammation
Carbamide peroxide oral topical solution is used as an oral debriding agent and oral wound cleanser for the 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.7 The oral topical solution also is used as an aid in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.7 Although carbamide peroxide oral topical solution is available for self-medication of these conditions, it should not replace professional care.
Carbamide peroxide oral topical solution has been used as an adjunct to oral hygiene when normal cleansing measures are inadequate or impossible (e.g., total-care geriatric patients) or as an adjunct to oral hygiene after regular brushing.
Carbamide peroxide is instilled topically into the external ear canal as a 6.5% otic solution.1, 2, 3, 4, 5, 6
Carbamide peroxide otic solution is for topical otic use only .1, 2, 3 Contact with the eyes should be avoided.2, 3, 4, 5, 6 If contact with the eyes occurs, the eyes should be flushed with water and a clinician should be consulted.3, 6
Hearing aids should be removed before administration of the otic solution.6
The patient should tilt their head sideways and 5-10 drops of the carbamide peroxide otic solution should be instilled into the ear without allowing the applicator tip to enter the ear canal.1, 2, 3, 4, 5, 6 The solution should be kept in the ear canal for several minutes by continuing to keep the head tilted or by placing cotton or an ear plug in the ear.1, 2, 3, 4, 5, 6
Foaming may occur in the ear canal and a crackling sound may be heard when the carbamide peroxide otic solution contacts cerumen (earwax) and oxygen is released.3, 4, 6
The container of carbamide peroxide otic solution should be recapped after each use.2, 4
Any cerumen remaining after treatment with carbamide peroxide otic solution may be removed by gently flushing the ear canal with warm water using a soft rubber bulb ear syringe.1, 2, 3, 4, 5, 6
Carbamide peroxide is applied topically to the mouth as a 10% oral topical solution.7
Carbamide peroxide oral topical solution is for oral topical use only and should not be swallowed.7 Contact with the eyes should be avoided.7
The commercially available carbamide peroxide 10% oral topical solution should not be diluted.7
The oral topical solution may be applied directly from the bottle onto affected mouth area(s) and then expectorated after 2-3 minutes.7
Alternatively, the oral topical solution may be used as a mouth rinse by placing 10-20 drops onto the tongue, mixing the solution with saliva by swishing it around in the mouth over the affected area(s) for at least 1 minute, and then expectorating.7
For use as an occasional aid to soften, loosen, and remove excessive cerumen (earwax) from the external ear canal in adults and children 12 years of age or older, 5-10 drops of carbamide peroxide 6.5% otic solution may be instilled into the external ear canal twice daily for up to 4 days or as directed by a clinician.1, 2, 3, 4, 5, 6 (See Otic Administration under Dosage and Administration: Administration.)
For self-medication , the otic solution may be used for up to 4 consecutive days if needed.1, 2, 3, 4, 5, 6 (See Precautions Related to Otic Use under Cautions: Precautions and Contraindications.)
Oral Irritation and Inflammation
For the topical treatment of canker sores (aphthous ulcers) and minor wounds or gum inflammation in adults and children 2 years of age or older, carbamide peroxide 10% oral topical solution may be used up to 4 times daily, after meals and at bedtime, or as directed by a clinician (dentist or physician).7
For each use, several drops of the 10% oral topical solution may be applied directly to affected mouth area(s) or, alternatively, 10-20 drops of the 10% oral topical solution may be used as a mouth rinse.7 (See Oral, Topical Use Only under Dosage and Administration: Administration.)
For self-medication , the oral topical solution may be used for up to 7 days.7 (See Precautions Related to Oral Topical Use under Cautions: Precautions and Contraindications.)
Ear pruritus has been reported following use of carbamide peroxide otic solution.8
Precautions and Contraindications
Precautions Related to Otic Use
Carbamide peroxide otic solution should not be used in patients who have had an allergic reaction to the solution.3
Patients should be instructed to contact a clinician before using carbamide peroxide otic solution if they have ear drainage or discharge, ear pain, irritation or rash in the ear, dizziness, ear injury, eardrum perforation, or have had ear surgery.1, 2, 3, 4, 5, 6
For self-medication , carbamide peroxide otic solution should not be used for more than 4 consecutive days, unless otherwise directed by a clinician.1, 2, 3, 4, 5, 6 Patients should be advised to discontinue use and contact a clinician if excessive cerumen (earwax) remains after using the otic solution for 4 consecutive days.1, 2, 3, 4, 5, 6
Patients should be advised not to use cotton swabs, toothpicks, hairpins, or other objects to remove earwax from the ear canal.6
Precautions Related to Oral Topical Use
Patients using carbamide peroxide solution for oral topical use should be advised to discontinue use and contact a clinician (dentist or physician) if swelling, rash, or fever develops or if irritation, pain, or redness in the mouth persists or worsens.7
For self-medication , carbamide peroxide oral topical solution should not be used for more than 7 days, unless otherwise directed by a clinician.7 Patients should be advised to discontinue use and contact a clinician if sore mouth symptoms have not improved after 7 days of treatment with the oral topical solution.7
Carbamide peroxide 6.5% otic solution should not be used in children younger than 12 years of age, unless otherwise directed by a clinician.1, 2, 3, 4, 5, 6
Carbamide peroxide 10% solution for oral topical use should not be used in children younger than 2 years of age, unless otherwise directed by a clinician.7 The oral topical solution should be used in children 2-12 years of age only if supervised by an adult.7
At least one manufacturer states that women who are pregnant or breast-feeding should consult a clinician before using carbamide peroxide 6.5% otic solution for self-medication .1
Carbamide peroxide serves as a source of hydrogen peroxide and nascent oxygen. When carbamide peroxide is exposed to moisture (e.g., on the skin, in the mouth), hydrogen peroxide and oxygen are released slowly. The effervescence caused by the release of oxygen mechanically removes debris from inaccessible regions. Carbamide peroxide, by releasing oxygen, has a mild mechanical loosening effect on cerumen (earwax) that has been softened by anhydrous glycerin contained in the preparation. Carbamide peroxide has weak antibacterial properties as the result of the release of oxygen (see Hydrogen Peroxide 52:28). Carbamide peroxide also may have a deodorant action, probably by inhibiting odor-causing bacteria.
Carbamide peroxide is a source of hydrogen peroxide. The drug is an equimolar compound of urea (carbamide) and hydrogen peroxide that can release about 35% hydrogen peroxide when exposed to water. Carbamide peroxide occurs as white crystals or as a crystalline powder, and has a solubility of 0.4 g/mL in water.
Carbamide peroxide is commercially available as a 6.5% otic solution that contains anhydrous glycerin and various excipients.1, 2, 3, 4, 5, 6 The drug also is commercially available for oral topical use as a 10% solution that contains glycerin and various excipients.7
Carbamide peroxide 6.5% otic solution should be stored at a room temperature2 of less than 25°C4 or 15-30°C,1, 2 depending on the manufacturer. The otic solution should not be exposed to excessive heat or direct sunlight.3, 5, 6
Carbamide peroxide 10% oral topical solution should be stored at less than 25°C.7
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Otic | Solution | 6.5%* | Auralyt® Liquid | Menper |
Auro® Liquid | Insight | |||
Clearcanal® Drops | NeilMed | |||
Debrox® Liquid | Medtech | |||
Ear Wax Removing Drops | ||||
Murine® Liquid | Denison | |||
Oral (Topical Use Only) | Solution | 10% | Gly-Oxide® Liquid | Medtech |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions June 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Menper. Auralyt® (carbamide peroxide 6.5% liquid) patient information. Miami, FL; Undated. From Dailymed website. Accessed 2020 Jan 15.
2. Insight Pharmaceuticals. Auro® (carbamide peroxide 6.5% liquid) patient information. Langhorne, PA; Undated. From Dailymed website. Accessed 2020 Jan 15.
3. NeilMed Pharmaceuticals. Clearcanal® (carbamide peroxide 6.5% drops) patient information. Santa Rosa, CA; Undated. From Dailymed website. Accessed 2020 Jan 15.
4. Medtech Products. Debrox® (carbamide peroxide 6.5% liquid) patient information. Tarrytown, NY; Undated. From Dailymed website. Accessed 2020 Jan 15.
5. Cardinal Health. Carbamide peroxide 6.5% ear wax removing drops patient information. Dublin, OH; Undated. From Dailymed website. Accessed 2020 Jan 15.
6. Prestige Brands Holdings. Murine® (carbamide peroxide 6.5% liquid) patient information. Tarrytown, NY; Undated. From Dailymed website. Accessed 2020 Jan 15.
7. Medtech Products. Gly-Oxide® (carbamide peroxide 10% liquid) patient information. Tarrytown, NY; Undated. From Dailymed website. Accessed 2020 Jan 15.
8. Roland PS, Eaton DA, Gross RD et al. Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products. Arch Otolaryngol Head Neck Surg . 2004; 130:1175-7. [PubMed 15492164]