carbamide peroxide 6.50% kit

FDA Drug Profile — LEADER Earwax Removal Kit

Drug Details

Generic Name
carbamide peroxide 6.50% kit
Brand Names
LEADER Earwax Removal Kit
Application Number
M014
Sponsor
Cardinal Health, 110 dba Leader
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

Ask a doctor before use if you have: ear drainage or discharge ear pain, irritation, or rash in ear recently had ear surgery dizziness an injury or perforation of the eardrum