FDA Label for Healthmart Ear Wax Removal Drops

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:

• 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

Children under 12 years: consult a doctor

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?

1-800-328-5890 Weekdays 8:30-5:00 CST

Package Labeling:

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