HAL-HEN EARWAX REMOVAL SYSTEM- carbamide peroxide kit

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]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

HAL-HEN EARWAX REMOVAL SYSTEM 
carbamide peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69428-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69428-004-00	1 in 1 KIT	06/01/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL

Part 1 of 1

HAL HEN EARWAX REMOVAL AID DROPS 
carbamide peroxide solution/ drops

Product Information
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69428-001-00	1 in 1 BOX
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	05/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	06/01/2014

Labeler - Warner Tech-care Products, LLC (080326764)