FDA.reportPublic FDA data

Ear Wax Removal Aid Drops

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:20

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 four days if needed, or as directed by a doctor. ▪ any wax remaining after treatment may be removed by gently flushing t...

Label contents#

Full prescribing information#

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 if you have

OTC - ASK DOCTOR SECTION

  • 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 right away at (1-800-222-1222).

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 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

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.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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
Eaxr Wax Removal Aid Drops Carbamide Peroxide

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

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
68016-793-15Ear Wax Removal Aid Drops15 mL in 1 BOTTLE, DROPPERLIQUID156
68016-793-15Ear Wax Removal Aid Drops1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-793EAR WAX REMOVAL AID DROPS (CARBAMIDE PEROXIDE) LIQUID [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 2 package rows20241030_85ae80c1-2bc2-4c90-9559-63510d03e739.zip

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
68016-79368016-793-15

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
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
ADIPIC ACID76A0JE0FKJIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT

Source Document#

Source XML · Source PDF

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 PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
ndc (package): 68016-793-15
ndc (product): 68016-793
ndc11 (package): 68016079315
spl id: bbd28093-02a5-4201-abf5-13670eac97e4
spl set id: 85ae80c1-2bc2-4c90-9559-63510d03e739

Reported adverse events (FAERS/openFDA)#

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