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NDC 69428-0004-00 Hal-Hen Earwax Removal System Details

Hal-Hen Earwax Removal System

Hal-Hen Earwax Removal System is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Warner Tech-care Products, LLC. The primary component is .

Product Information

NDC	69428-0004
Product ID	69428-004_bd186eb7-e6c6-8af4-e053-2a95a90a1be5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hal-Hen Earwax Removal System
Proprietary Name Suffix	n/a
Non-Proprietary Name	CARBAMIDE PEROXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Warner Tech-care Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part344
Listing Certified Through	2022-12-31

Package

Package Images

NDC 69428-0004-00 (69428000400)

Pricing Information	N/A
NDC Package Code	69428-004-00
Billing NDC	69428000400
Package	1 KIT in 1 KIT (69428-004-00) * 1 BOTTLE in 1 BOX (69428-001-00) / 15 mL in 1 BOTTLE
Marketing Start Date	2014-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 50935e2d-b1fb-4fb0-aff3-fdde4dff9a36 Details

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 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 Administration	AURICULAR (OTIC)

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:69428-001-00	1 in 1 BOX
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	05/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	06/01/2014

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

Revised: 3/2021

Document Id: bd186eb7-e6c6-8af4-e053-2a95a90a1be5

Set id: 50935e2d-b1fb-4fb0-aff3-fdde4dff9a36

Version: 1

Effective Time: 20210309