FDA Label for Deluxe Ear Wash System

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

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 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 the Deluxe Ear Washer
• 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 in bottle when not in use
• Product foams on contact with earwax due to release of oxygen. There may be an assoiciated crackling sound.
• Do not use if tamper-evident safety seal is broken or missing

Inactive Ingredients

citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water, tartaric acid

Questions?

1-800--547-5492

Package Labeling:

q - q