Hal-Hen Earwax Removal System

Hal-Hen Earwax Removal System by

Drug Labeling and Warnings

Hal-Hen Earwax Removal System by is a Otc medication manufactured, distributed, or labeled by Warner Tech-care Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAL-HEN EARWAX REMOVAL SYSTEM- carbamide peroxide 
Warner Tech-care Products, LLC

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Hal-Hen Earwax Removal System

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 earwax

Warnings

For use in the ear only

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 ear drum
  • 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 4 days
  • excessive earwax remains after use of this product

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

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

  • 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

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

Questions?

1-800-242-5436

Package Labeling: Kit

Kit

Package Labeling:

Label

HAL-HEN EARWAX REMOVAL SYSTEM 
carbamide peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69428-004
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69428-004-001 in 1 KIT06/01/201409/11/2025
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
HAL HEN EARWAX REMOVAL AID DROPS 
carbamide peroxide solution/ drops
Product Information
Item Code (Source)NDC: 69428-001
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69428-001-001 in 1 BOX
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01405/01/201409/11/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01406/01/201409/11/2025
Labeler - Warner Tech-care Products, LLC (080326764)

Revised: 2/2025
Document Id: 2ea8bfc6-f6a9-603c-e063-6394a90aeb68
Set id: 50935e2d-b1fb-4fb0-aff3-fdde4dff9a36
Version: 3
Effective Time: 20250221