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FDA LABEL GENERIC: Carbamide Peroxide MFR: Bell Pharmaceuticals, Inc.

Otix 6.5 % Otic Solution

Carbamide peroxide 6.5%

Earwax removal aid

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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 a soft rubber bulb ear syringe Children Under 12 years: consult a doctor
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
anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

1-800-328-5890

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