Carbamide Peroxide Otic drops, solution

What is this medicine?

CARBAMIDE PEROXIDE (CAR bah mide per OX ide) is used to soften and help remove ear wax.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dizziness
• ear discharge
• ear pain, irritation or rash
• infection
• perforated eardrum (hole in eardrum)
• an unusual or allergic reaction to carbamide peroxide, glycerin, hydrogen peroxide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is only for use in the outer ear canal. Follow the directions carefully. Wash hands before and after use. The solution may be warmed by holding the bottle in the hand for 1 to 2 minutes. Lie with the affected ear facing upward. Place the proper number of drops into the ear canal. After the drops are instilled, remain lying with the affected ear upward for 5 minutes to help the drops stay in the ear canal. A cotton ball may be gently inserted at the ear opening for no longer than 5 to 10 minutes to ensure retention. Repeat, if necessary, for the opposite ear. Do not touch the tip of the dropper to the ear, fingertips, or other surface. Do not rinse the dropper after use. Keep container tightly closed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be used in children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other ear products without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine is not for long-term use. Do not use for more than 4 days without checking with your health care professional. Contact your doctor or health care professional if your condition does not start to get better within a few days or if you notice burning, redness, itching or swelling.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• burning, itching, and redness
• worsening ear pain
• rash

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• abnormal sensation while putting the drops in the ear
• temporary reduction in hearing (but not complete loss of hearing)

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) in a tight, light-resistant container. Keep bottle away from excessive heat and direct sunlight. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.