carbamide peroxide 6.50% kit

FDA Drug Profile — Freskaro Earwax Removal Aid

Drug Details

Generic Name
carbamide peroxide 6.50% kit
Brand Names
Freskaro Earwax Removal Aid
Application Number
M014
Sponsor
Pharma Nobis, LLC
NDC Codes
1
Dosage Forms
LIQUID
Routes
AURICULAR (OTIC)
Active Ingredients
CARBAMIDE PEROXIDE

Indications and Usage

For occasional use as an aid to soften, loosen, and remove excessive earwax.

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) of the ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.