FDA.reportPublic FDA data

Hal-Hen Earwax Removal System

Manufacturer
Warner Tech-care Products, LLC
Effective date
2025-02-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:41:09

Label at a glance#

ProductHal-Hen Earwax Removal System
Active ingredientCARBAMIDE PEROXIDE
Label structure9 sections

Indications and uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Dosage and administration

FOR USE IN THE EAR ONLY Adult and children over 12 years of age: Tilt head sideways and place 5 to 10 drops into ear 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, u...

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 earwax

Warnings

WARNINGS SECTION

For use in the ear only

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 ear drum
  • 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 4 days
  • excessive earwax remains after use of 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.

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY

Adult and children over 12 years of age:

  • Tilt head sideways and place 5 to 10 drops into ear
  • 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: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated cracking sound.
  • Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

OTC - QUESTIONS SECTION

1-800-242-5436

Package Labeling: Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69428-001HAL-HEN EARWAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE) KIT [WARNER TECH-CARE PRODUCTS, LLC]3Legacy NDC20250223_50935e2d-b1fb-4fb0-aff3-fdde4dff9a36.zip
69428-004HAL-HEN EARWAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE) KIT [WARNER TECH-CARE PRODUCTS, LLC]3Legacy NDC20250223_50935e2d-b1fb-4fb0-aff3-fdde4dff9a36.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69428-00469428-004-00
69428-00169428-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

Source Document#

Source XML

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
2ea8bfc6-f6a9-603c-e063-6394a90aeb6850935e2d-b1fb-4fb0-aff3-fdde4dff9a362025-02-21WarningsExact identifier
spl id: 2ea8bfc6-f6a9-603c-e063-6394a90aeb68
spl set id: 50935e2d-b1fb-4fb0-aff3-fdde4dff9a36

Reported adverse events (FAERS/openFDA)#

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