DEBROX CARBAMIDE PEROXIDE A-S MEDICATION SOLUTIONS FDA Approved Uses For occasional use as an aid to soften, loosen, and remove excessive earwax
FunFoxMeds bottle
Substance Carbamide Peroxide
Route
AURICULAR (OTIC)
Applications
M014
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Carbamide peroxide 6.5% non USP
Inactive Ingredients
Inactive Ingredients citric acid flavor glycerin propylene glycol sodium lauroyl sarcosinate water
Strengths
15 ml 6.5 %
Quantities
15 ml
Treats Conditions
Uses For Occasional Use As An Aid To Soften Loosen And Remove Excessive Earwax

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
31PZ2VAU81
Packaging

HOW SUPPLIED Product: 50090-4201 NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON; Carbamide Peroxide Label Image

Package Descriptions
  • HOW SUPPLIED Product: 50090-4201 NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON
  • Carbamide Peroxide Label Image

Overview

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

Indications & Usage

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

Dosage & Administration

Directions FOR USE IN THE EAR ONLY adults and children over 12 years of age: tilt head sideways place 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in ear • use twice daily for up to four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe children under 12 years: consult a doctor

Warnings & Precautions
Warnings Ask a doctor before use if you have ear drainage or discharge • ear pain irritation or rash in the ear • dizziness an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than four days excessive earwax remains after use of this product
Purpose

Purpose Earwax removal aid

When Using

When using this product avoid contact with the eyes

Stop Use & Ask a Doctor

Stop use and ask a doctor if you need to use for more than four days excessive earwax remains after use of this product

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Questions

Questions? 1-866-255-5202 Debrox.com


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