EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid

Ear Wax Removal Aid Drops by

Drug Labeling and Warnings

Ear Wax Removal Aid Drops by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax

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 ear wax remains after use this product

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

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 canal.
• ▪ 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 flushing the ear with warm water, using a soft rubber bulb ear syringe.

Children under 12 years of age: consult a doctor.

Other information

• ▪ Store at room temperature
  
• ▪ Avoid exposing bottle to excessive heat and direct sunlight
  
• ▪ Store bottle in the outer carton
  
• ▪ Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.
  
• ▪ Keep cap on bottle when not in use

Inactive ingredients

adipic acid, anhydrous glycerin, polysorbate 80.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC: 68016-793-15

*COMPARE TO THE ACTIVE INGREDIENT IN DEBROX® DROPS

EAR WAX REMOVAL AID DROPS KIT

Carbamide Peroxide 6.5%

Ear Wax Removal Aid

• Safe & Gentle
• Microfoam Cleansing Action
• Easy to use Instructions

NET WT 0.5 FL OZ (15 mL)

This kit include soft rubber bulb ear syringe and drops

TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN

IMPORTANT: Keep the carton for future reference on full labeling.

Distributed BY:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox® Drops.

INGREDIENTS AND APPEARANCE

EAR WAX REMOVAL AID DROPS 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-793
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 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-793-15	1 in 1 CARTON	04/18/2019
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	04/18/2019

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)