Earwax Removal Kit

FDA Drug Profile — Carbamide peroxide 6.5%

Drug Details

Generic Name
Earwax Removal Kit
Brand Names
Carbamide peroxide 6.5%
Application Number
M014
Sponsor
Allegiant Health
NDC Codes
1
Dosage Forms
SOLUTION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients
CARBAMIDE PEROXIDE

Indications and Usage

Use(s) For occasional use as an aid to soften, loosen and remove excessive earwax.

Warnings

Warnings Do not use if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor for more than 4 days; if excessive earwax remains after use of this product, consult a doctor When using this product • avoid contact with eyes. If accidental contact with eyes occurs, flush eyes with water and consult a doctor Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.