HEALTHMART EARWAX REMOVAL KIT EAR WAX DROPS AND BULB- carbamide peroxide kit

HealthMart Earwax Removal Kit Ear wax drops and Bulb by

Drug Labeling and Warnings

HealthMart Earwax Removal Kit Ear wax drops and Bulb by is a Otc medication manufactured, distributed, or labeled by McKesson Corp via Strategic Sourcing Services LLC, Bell Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Ear wax removal aid

Uses

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

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 ear wax remains after use of this product

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

FOR USE IN THE EAR ONLYAdults and children over 12 years of age:

consult a doctor Children under 12 years:

• 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

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 ear wax due to release of oxygen. There may be an associated crackling 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?

1-800-328-5890

Drug Facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Ear wax removal aid

Uses

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

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 ear wax remains after use of this product

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

FOR USE IN THE EAR ONLYAdults and children over 12 years of age:

consult a doctor Children under 12 years:

• 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

Other information

• Avoid exposing bottle to excessive heat and direct sunlight 
• Store bottle in the outer carton
• Do not store above 25°C (77°F)
• Keep cap on bottle when not in use
• Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling 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?

 Weekdays 8:30-5:00 CST 1-800-328-5890

Package Labeling:Kit

Package Labeling:62011-0483-1

INGREDIENTS AND APPEARANCE

HEALTHMART EARWAX REMOVAL KIT EAR WAX DROPS AND BULB 
carbamide peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62011-0484

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62011-0484-1	1 in 1 KIT	02/25/2022

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

Part 1 of 1

HEALTHMART EAR WAX REMOVAL DROPS 
carbamide peroxide solution/ drops

Product Information
Item Code (Source)	NDC: 62011-0483
Route of Administration	TOPICAL

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: 62011-0483-1	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	02/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	02/25/2022

Labeler - McKesson Corp via Strategic Sourcing Services LLC (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals, Inc.		140653770	manufacture(62011-0484)