Alone, or in combination with anhydrous glycerin, in short-term local treatment and hygienic prevention of minor infections, inflammation, and/or irritation of the gums and mouth (e.g., canker sores, gingivitis, periodontitis, stomatitis, and Vincent’s infection).
Treatment of minor inflammation caused by dentures, mouth appliances (orthodontics), or dental procedures.
Self-medication as an adjunct in oral hygiene when normal cleansing measures are inadequate or impossible (e.g., total-care geriatric patients) or after regular brushing.
Cleanses and debrides accessible oral lesions and inflammation; may provide a soothing, protective effect.
Cerumen Removal
Self-medication therapy as an adjunct for the removal of hardened or tightly packed cerumen from the external ear canal in combination with anhydrous glycerin. Aids in the prevention of ceruminosis (excessive ear wax formation).
Dosage and Administration
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.
Oral Topical Administration
Administer commercially available 10 or 15% oral solution as a topical or rinse. Avoid contact with the eyes. Do not swallow. Do not dilute.
Apply oral solution with an applicator or cotton swab to the affected area of the mouth after meals and at bedtime. Expectorate in 1–3 minutes. Rinse applicator after use.
As a mouthwash, apply oral solution to tongue, mix with saliva, swish around in the mouth over affected area for ≥1 minute, then expectorate.
As an adjunct for orthodontics, after brushing, swish oral solution vigorously for 2–3 minutes, then expectorate.
As an adjunct for patients unable to practice normal oral hygiene, after meals, swish oral solution vigorously, then expectorate.
Do not rinse the mouth or drink for ≥5 minutes.
Alternatively, for everyday use, apply to toothbrush, cover with toothpaste, brush normally, and expectorate.
Otic Administration
In fixed combination with glycerin, instill into the external ear as an otic solution. Solution will foam on contact with cerumen. Avoid contact with eyes.
Remove hearing aids before administration of solution.
Tilt head sideways; do not insert applicator tip into the ear canal.
Keep solution in ear canal for at least 15 minutes (maintain tilted head or place cotton in the ear).
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. Do not insert syringe tip into ear canal; do not allow tip of syringe to obstruct the flow of water leaving the ear.
Dosage
Pediatric Patients
Oral Irritation and Inflammation
Oral Topical
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.
Children ≥2 years of age: As a rinse, apply 10–20 drops of the 10% solution onto the tongue.
Cerumen Removal
Otic
Children ≥12 years of age: Instill 5–10 drops into the external ear canal twice daily as needed for up to 4 consecutive days.
Adults
Oral Irritation and Inflammation
Oral Topical
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.
As a rinse: Apply 10–20 drops of the 10% solution onto the tongue.
As an adjunct for patients unable to practice normal oral hygiene: Use ≥10 drops of the 10% solution after meals.
As an adjunct for orthodontics: Use ≥10 drops of the 10% solution after brushing.
Cerumen Removal
Otic
Instill 5–10 drops into the external ear canal twice daily as needed for up to 4 consecutive days.
Prescribing Limits
Pediatric Patients
Oral Irritation and Inflammation
Oral Topical
Children ≥ 2 years of age: Maximum 7 days for self-medication.
Cerumen Removal
Otic
Children ≥12 years of age: Maximum 4 days for self-medication.
Adults
Oral Irritation and Inflammation
Oral Topical
Maximum 7 days for self-medication.
Cerumen Removal
Otic
Maximum 4 days for self-medication.
Special Populations
No special population dosage recommendations at this time.
Cautions
Warnings/Precautions
Warnings
Oral Inflammation
If swelling, rash, or fever develops, or if irritation, pain, or redness persists or worsens, discontinue use and contact clinician.
If sore mouth symptoms do not improve in ≤7 days, discontinue use and contact clinician.
Otic Conditions
Not for self-medication if patient has ear drainage or discharge, ear pain or redness, rash, irritation, tenderness, or dizziness. Also not for self-medication in known or suspected ear injury or infection, eardrum perforation, or after ear surgery.
Specific Populations
Pediatric Use
Safety and efficacy of oral solution not established in children <2 years of age.
Safety and efficacy of otic solution not established in children <12 years of age.
Supervise children <12 years of age during use of oral solution.
Interactions
No formal drug interaction studies to date.
Stability
Storage
Oral Topical
Solution
Tight, light-resistant container; protect from heat and direct sunlight.
Otic
Solution
Tight, light-resistant container; protect from heat and direct sunlight.
Actions
Effervescence from the release of oxygen mechanically removes debris from inaccessible regions.
Exposure to moisture (e.g., on the skin, in the mouth) slowly releases hydrogen peroxide and oxygen; release of oxygen results in weak antibacterial properties.
Probably inhibits odor-causing bacteria, resulting in deodorant activity.
For otic use, penetrates and softens cerumen while the release of oxygen provides a mild mechanical action resulting in loosening of the softened cerumen.
Advice to Patients
Importance of discontinuing use of oral solution and contacting a clinician if swelling, rash, or fever develops; if irritation, pain, or redness persists; or if symptoms worsen or do not improve in 7 days.
Advise patients not to use oral preparations for >7 days, unless otherwise directed by a clinician.
Importance of contacting a clinician before using otic solution if patient has ear drainage or discharge, ear pain or redness, rash, irritation, tenderness, or dizziness.
Advise patients not to use otic solution if patient has an ear injury or perforated eardrum, or after ear surgery, unless directed by a clinician.
Inform patients not to use otic solution for >4 consecutive days, unless otherwise instructed by a clinician. Importance of contacting clinician if excessive ear wax remains after using otic solution for 4 consecutive days.
Advise patients not to use cotton swabs, toothpicks, hairpins, or other instruments to remove wax from ear canal.
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.
Carbamide Peroxide
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Otic
Solution
6.5%*
Auro® Ear Wax Removal Aid (with anhydrous glycerin and propylene glycol)
Del
Debrox® Drops (with glycerin and propylene glycol)
GlaxoSmithKline
E.R.O.® Ear Drops (with anhydrous glycerin)
Scherer
Mollifene® Ear Wax Removing Formula (with anhydrous glycerin and propylene glycol)
Pfeiffer
Murine® Ear Drops (with alcohol 6.3% and anhydrous glycerin)
Prestige
Murine® Ear Wax Removal System (with alcohol 6.3% and anhydrous glycerin; available with otic syringe)
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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