ENT ESSENTIALS EAR WAX REMVOER- carbamide peroxide liquid

ENT Essentials Ear Wax Remvoer by

Drug Labeling and Warnings

ENT Essentials Ear Wax Remvoer by is a Otc medication manufactured, distributed, or labeled by Wisconsin Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Carbamide Peroxide 6.5%

PURPOSE

Purpose

Earwax removal aid

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

ASK DOCTOR

Aska 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

When using this product avoid contact wtih the eyes

STOP USE

Stop use and aks 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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

D irections

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 the 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 flusing the ear with warm water, using a soft rubber bulb ear syringe.

Children under 12 years: consult a doctor.

OTHER SAFETY INFORMATION

Other informaiton

• store bottle in teh outer carton
• product foams on contact with earwax due to the release of oxygen. Theremay be an associated "crackling" sound
• keep cap on bottle when not in use

INACTIVE INGREDIENT

Inactive ingredients

Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid

QUESTIONS

Questions or comments? 1-800-635-3696

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ENT ESSENTIALS EAR WAX REMVOER 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68093-4503
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.065 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68093-4503-1	1 in 1 CARTON	02/01/2017
1		22 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/01/2017

Labeler - Wisconsin Pharmacal Company (800873986)

Establishment
Name	Address	ID/FEI	Business Operations
Wisconsin Pharmacal Company		800873986	manufacture(68093-4503)