Version May 2024
Ear wax removal: Otic: Instill 5 to 10 drops twice daily up to 4 days.
Mouth, gum, or dental irritation: Oral: Use up to 4 times daily after meals and at bedtime.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Carbamide peroxide: Pediatric drug information")
Ear wax removal:
Children <12 years: Limited data available: Otic (6.5% solution): Usual range: 1 to 5 drops twice daily for up to 4 days; individualize the dose according to patient size (Dimmitt 2005)
Children ≥12 years and Adolescents: Otic (6.5% solution): Instill 5 to 10 drops twice daily for up to 4 days
Mouth, gum, or dental irritation: Children ≥2 years and Adolescents: Oral (10% solution): Use up to 4 times daily after meals and at bedtime either by direct application to the affected area or as an oral rinse for up to 7 days. For direct application, place several drops undiluted on affected area then expectorate after 2 to 3 minutes. For use as an oral rinse, place 10 to 20 drops onto tongue, mix with saliva, swish for ≥1 minute, then expectorate.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Dermatologic: Localized erythema, skin rash
Infection: Superinfection
Local: Local irritation, redness
Dosage form specific issues:
• Oral: Self-medication (OTC) use: Instruct patient to discontinue use and consult health care provider if swelling, rash, or fever develops or if irritation, pain, or redness persists or worsens. Patients should consult health care provider for use longer than 7 days.
• Otic: Self-medication (OTC) use: Instruct patient to consult health care provider prior to use if ear drainage or discharge, ear pain, irritation, rash in ear, dizziness, or eardrum perforation is present or if they had recent ear surgery. Patients should consult health care provider for use longer than 4 days or if condition persists.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Mouth/Throat:
Gly-Oxide: 10% (15 mL [DSC], 60 mL [DSC]) [contains propylene glycol]
Solution, Otic:
Clearcanal Earwax Softener: 6.5% (15 mL) [alcohol free]
Clinere Earwax Removal Kit: 6.5% (15 mL) [contains propylene glycol]
Ear Drops: 6.5% (15 mL) [contains propylene glycol]
Ear Drops Earwax Aid: 6.5% (15 mL [DSC]) [contains propylene glycol]
FT Earwax Removal: 6.5% (15 mL) [contains propylene glycol]
FT Earwax Removal Kit: 6.5% (15 mL) [contains propylene glycol]
GoodSense Ear Wax Kit: 6.5% (15 mL) [contains propylene glycol]
GoodSense Ear Wax Removal: 6.5% (15 mL) [contains propylene glycol]
Yes
Solution (Clearcanal Earwax Softener Otic)
6.5% (per mL): $0.20
Solution (Clinere Earwax Removal Kit Otic)
6.5% (per mL): $0.65
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: For topical use only; do not swallow. Not for ophthalmic use. For direct application, place several drops undiluted on affected area then expectorate after 2 to 3 minutes or for use as an oral rinse, place 10 to 20 drops onto tongue, mix with saliva, swish for ≥1 minute, then expectorate.
Otic: Tilt head sideways and apply drops into ear. Solution will foam on contact with earwax; a crackling sound may occur. Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear. Remaining wax after treatment may be removed by gently flushing ear with warm water using a soft rubber bulb ear syringe. Do not allow applicator tip to enter ear canal.
Oral: For topical use only; do not swallow. For direct application, place several drops undiluted solution on affected area with an applicator or cotton swab then expectorate after 2 to 3 minutes. For use as an oral rinse, place drops onto tongue, mix with saliva, swish for ≥1 minute, then expectorate. Patient should not rinse mouth or drink fluids for 5 minutes after oral administration.
Otic: For otic use only. Prior to use, may warm by holding bottle in hands. Tilt head sideways and apply drops into ear. For children younger than 3 years of age, pull the outer ear outward and downward. For children 3 years of age and older, pull the outer ear outward and upward. Solution will foam on contact with earwax; a crackling sound may occur. Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear. Remaining wax after treatment may be removed by gently flushing ear with warm water using a soft rubber bulb ear syringe. Do not allow applicator tip to enter ear canal.
Oral: Temporary use in cleansing of canker sore and minor wounds or gum inflammation due to minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of mouth and gums; aids in removal of phlegm, mucus, or other secretions associated with occasional sore mouth.
Otic: Aid to soften, loosen, and remove excessive earwax.
None known.
There are no known significant interactions.
Carbamide peroxide releases hydrogen peroxide which serves as a source of nascent oxygen upon contact with catalase; deodorant action is probably due to inhibition of odor-causing bacteria; softens impacted cerumen due to its foaming action
Onset of action: ~24 hours
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