EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid 
BETTER LIVING BRANDS, 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.

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Ear Wax Removal Aid Drops

Drug Facts

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 (1-800-222-1222) right away.

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 4 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? 1-866-467-2748

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Debrox® Drops

NDC 21130-793-15

Ear Wax Removal Aid Drops
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)

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

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

IMPORTANT: Keep this carton for future labeling.

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

Ear Wax Removal Aid Drops
EAR WAX REMOVAL AID DROPS 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-793
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID (UNII: 76A0JE0FKJ)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-793-151 in 1 CARTON01/13/2020
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34401/13/2020
Labeler - BETTER LIVING BRANDS, LLC (009137209)

Revised: 11/2021
Document Id: 7fe7213e-cfa8-40b1-a815-f6cce634c22f
Set id: 3bded237-4d2c-4b38-bedc-267fdc374194
Version: 2
Effective Time: 20211124
 
BETTER LIVING BRANDS, LLC