FDA Label for Topcare Earwax Removal Kit

Drug Facts

Active Ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, looser, 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
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 by keeping head titled 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 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

Other

*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Distributed By Topco Associates LLC  ELK Frove Village, IL 60007  Topco  BPH414  Questions? 1-888-423-0139  [email protected]

Product Label

Box - Box