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 ONLY

Adults 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 bykeeping 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:

Label

HEALTHMART EAR WAX REMOVAL DROPS
carbamide peroxide solution/ drops

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

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	Marketing Start Date
Packaging
1	NDC:62011-0483-1	1 in 1 BOX	02/25/2022
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 Drug	M014	02/25/2022

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

Name	Address	ID/FEI	Business Operations
Establishment
Bell Pharmaceuticals, Inc.		140653770	manufacture(62011-0483)

HealthMart Ear Wax Removal Drops