Yes

Otic Agent, Cerumenolytic

Relief of minor inflammation of gums, oral mucosal surfaces and lips including canker sores and dental irritation; emulsify and disperse ear wax

C

Otic preparation should not be used in patients with a perforated tympanic membrane; ear drainage, ear pain or rash in the ear; do not use in the eye; do not use otic preparation longer than 4 days; oral preparation should not be used in children <3 years

Oral: With prolonged use of oral carbamide peroxide, there is a potential for overgrowth of opportunistic organisms; damage to periodontal tissues; delayed wound healing; should not be used for longer than 7 days

Otic: Do not use if ear drainage or discharge, ear pain, irritation, or rash in ear; should not be used for longer than 4 days

1% to 10%:

Local: Irritation, redness

Miscellaneous: Superinfections

No data reported

Store in tight, light-resistant containers; oral gel should be stored under refrigeration

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 effect: Slight disintegration of hard ear wax in 24 hours

Children and Adults:

Oral solution (should not be used for >7 days): Oral preparation should not be used in children <3 years of age; apply several drops undiluted on affected area 4 times/day after meals and at bedtime; expectorate after 2-3 minutes or place 10 drops onto tongue, mix with saliva, swish for several minutes, expectorate

Otic:

Children <12 years: Tilt head sideways and individualize the dose according to patient size; 3 drops (range: 1-5 drops) twice daily for up to 4 days, tip of applicator should not enter ear canal; keep drops in ear for several minutes by keeping head tilted and placing cotton in ear

Children greater than or equal to 12 years and Adults: Tilt head sideways and instill 5-10 drops twice daily up to 4 days, tip of applicator should not enter ear canal; keep drops in ear for several minutes by keeping head tilted and placing cotton in ear

None reported

None reported

No information available to require special precautions

No effects or complications reported

Contact physician if dizziness or otic redness, rash, irritation, tenderness, pain, drainage, or discharge develop; do not drink or rinse mouth for 5 minutes after oral use of gel

Patient may complain of foaming

Gel, oral (Proxigel®): 10% (34 g)

Solution:

Oral:

Gly-Oxide®: 10% in glycerin (15 mL, 60 mL)

Orajel® Perioseptic®: 15% in glycerin (13.3 mL)

Otic (Auro® Ear Drops, Debrox®, Mollifene® Ear Wax Removing, Murine® Ear Drops): 6.5% in glycerin (15 mL, 30 mL)