Carbamide Peroxide Otic Solution

• It is used to soften earwax so it may be taken out.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where carbamide peroxide otic solution is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in the carton to protect from light.
• Protect from heat.
• Put the cap back on after you are done using your dose.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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 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.

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

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.

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.

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.