DrugindexOnline^{2nd edition}

Generic Name: Carbamide Peroxide Otic Solution (CAR-bah-mide per-ox-ide)
Brand Name: Examples include Auro and Debrox

Debrox Solution is used for:

Softening, loosening, and removing excessive earwax.

Debrox Solution is a form of peroxide. It works by softening and removing earwax.

Do NOT use Debrox Solution if:

• you are allergic to any ingredient in Debrox Solution
• you have ear drainage or discharge, ear pain, irritation, rash in the ear, ear injury, hole in the eardrum, broken eardrum, or recent ear surgery
• you are dizzy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Debrox Solution:

Some medical conditions may interact with Debrox Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Debrox Solution. Because little, if any, of Debrox Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Debrox Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Debrox Solution:

Use Debrox Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• This medicine is for use in the ear only. Avoid contact with other mucous membranes and eyes.
• To use ear drops, lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
• Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
• Use twice daily for 4 days if necessary, or as directed by your doctor. Do not use Debrox Solution for more than 4 days without talking to your doctor.
• If you miss a dose of Debrox Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Debrox Solution.

Important safety information:

• If excessive earwax remains after use of Debrox Solution, contact your doctor.
• Debrox Solution is not recommended for use in CHILDREN younger than 12 years of age except under the advice of a doctor.
• PREGNANCY and BREAST-FEEDING: It is unknown if Debrox Solution can cause harm to the fetus. If you become pregnant while taking Debrox Solution, discuss with your doctor the benefits and risks of using Debrox Solution during pregnancy. It is unknown if Debrox Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Debrox Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Debrox Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm ), or emergency room immediately.

Proper storage of Debrox Solution:

Store Debrox Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Debrox Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Debrox Solution, please talk with your doctor, pharmacist, or other health care provider.
• Debrox Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Debrox Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.