Debrox (for the ears) is used to soften and loosen ear wax, making it easier to remove.

Debrox may also be used for purposes not listed in this medication guide.

You should not use Debrox if you have a hole in your ear drum (ruptured ear drum), or if you have any signs of ear infection or injury, such as pain, warmth, swelling, drainage, or bleeding.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Debrox comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after using Debrox.

To use the ear drops:

• Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.

• Hold the dropper upside down over your ear and drop the correct number of drops into the ear.

• You may hear a bubbling sound inside your ear. This is caused by the foaming action of Debrox, which helps break up the wax inside your ear.

• Stay lying down or with your head tilted for at least 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out. Follow your doctor's instructions about the use of cotton.

• Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Debrox may be packaged with a bulb syringe that is used to flush out your ear with water. To use the bulb syringe:

• Fill the syringe with warm water that is body temperature (no warmer than 98 degrees F). Do not use hot or cold water.

• Hold your head sideways with your ear over a sink or bowl. Gently pull your ear back to open the ear canal. Place the tip of the bulb syringe at the opening of your ear canal. Do not insert the tip into your ear.

• Squeeze the bulb syringe gently to release the water into your ear. Do not squirt the water with any force, or you could damage your ear drum.

• Remove the syringe and allow the water to drain from your ear into the sink or bowl.

Do not use Debrox for longer than 4 days in a row. Call your doctor if you still have excessive earwax after using this medicine, or if your symptoms get worse.

Clean the bulb syringe by filling it with plain water and emptying it several times. Do not use soap or other cleaning chemicals. Allow the syringe to air dry.

Keep the medicine bottle tightly closed and store it in the outer carton at room temperature, away from moisture and heat.

You should not use Debrox if you are allergic to it, or if you have a hole in your ear drum (ruptured ear drum).

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• recent ear surgery or injury;

• ear pain, itching, or other irritation;

• drainage, discharge, or bleeding from the ear; or

• warmth or swelling around the ear.

Debrox should not be used on a child younger than 12 years old.

Since Debrox otic is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

An overdose of carbamide peroxide otic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid getting Debrox in your eyes or mouth.

Do not use other ear drops unless your doctor has told you to.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Debrox may cause serious side effects. Stop using Debrox and call your doctor at once if you have:

• dizziness; or

• new or worsening ear problems.

Common side effects of Debrox may include:

• a foaming or crackling sound in the ear after using the ear drops;

• temporary decrease in hearing after using the drops;

• mild feeling of fullness in the ear; or

• mild itching inside the ear.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.