FDA.reportPublic FDA data

Ear Wax Removal Aid Drops

Manufacturer
BETTER LIVING BRANDS, LLC
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:41:14

Label at a glance#

ProductEar Wax Removal Aid Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use for more than four days
  • excessive ear wax remains after use this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

adipic acid, anhydrous glycerin, polysorbate 80

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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
Ear Wax Removal KIT 0.5 Fl oz. 15 mL
Ear Wax Removal KIT 0.5 Fl oz. 15 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN6
702050carbamide peroxide 65 MG/ML Otic SolutionSCD6
702050carbamide peroxide 6.5 % Otic SolutionSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130321130136361GTIN-13: 0321130136361
EAN-13: 0321130136361
GTIN-12: 321130136361
UPC-A: 321130136361
GTIN storage (14 digits): 00321130136361		murine-ear-wax-removal-drops-01.jpg
QR code linkQR Codealbtsn.com/ugtfhj0793KIT15SC.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-793-15Ear Wax Removal Aid Drops15 mL in 1 BOTTLE, DROPPERLIQUID156
21130-793-15Ear Wax Removal Aid Drops1 in 1 CARTONLIQUID16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-79321130-793-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-04full-release2026-06-01 00:33:55

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEBETTER LIVING BRANDS, LLC3bded237-4d2c-4b38-bedc-267fdc3741942025-10-29WarningsExact identifier
ndc (package): 21130-793-15
ndc (product): 21130-793
ndc11 (package): 21130079315
spl id: 424a5b21-d76f-f943-e063-6394a90a50cc
spl set id: 3bded237-4d2c-4b38-bedc-267fdc374194

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.