Debrox otic

You should not use this medicine 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.

Carbamide peroxide otic 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 this medicine.

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 carbamide peroxide, 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.

Carbamide peroxide 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 carbamide peroxide 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.

Since carbamide peroxide 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.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: other ear problems (e.g., ear drainage, infection, pain, rash, injury, recent ear surgery, hole/perforation in the eardrum), dizziness.

Tell your doctor if you are pregnant or breast-feeding before using this medication.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from direct sunlight and heat. Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all drug products away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Applies to carbamide peroxide otic: otic solution

General

Carbamide peroxide otic (the active ingredient contained in Debrox) is generally well tolerated.[Ref]

Some side effects of Debrox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.