Ear Wax Removal Aid Drops: Package Insert and Label Information

EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid
PHARMACY VALUE ALLIANCE, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

Eaxr Wax Removal Aid Drops Carbamide Peroxide
(click image for full-size original)
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) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE 0.065 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID
GLYCERIN
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68016-793-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (68016-793-15)
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)

Revised: 09/2022 PHARMACY VALUE ALLIANCE, LLC

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