Chloroxylenol; Hydrocortisone; Pramoxine ear drops

What is this medication?

CHLOROXYLENOL; HYDROCORTISONE; PRAMOXINE (klor oh ZYE le nole; hye droe KOR ti sone; pra MOX een) is used to treat infections of the outer ear canal, like swimmer's ear. It also relieves minor ear pain and itching.

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

COMMON BRAND NAME(S): Aero Otic HC, Cortane B, Cortic, Cortic ND, Cyotic, Exotic-HC, Mediotic-HC, OtiRx, Oto-End, Otomar, Otomar-HC, Otozone, Pramoxine-HC, RE Pramoxine-HC, Tri-Otic, Zolene-HC, Zotane-HC, Zoto-HC

What should I tell my care team before I take this medication?

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

• any active infection
• ear discharge
• perforated eardrum
• an unusual or allergic reaction to chloroxylenol, hydrocortisone, pramoxine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is only for use in the ears. Follow the directions on the prescription label. Wash hands before and after use. Gently warm the bottle by holding it in the hand for 1 to 2 minutes. Lie down on your side with the infected ear facing upward. Try not to touch the tip of the dropper to your ear, fingertips, or other surface. Instill the correct number of drops into the ear. Stay in this position for 30 to 60 seconds to help the drops soak into the ear. Repeat the steps for the other ear if both ears are infected. Do not use your medicine more often than directed. Finish the full course of medicine prescribed by your doctor or health care professional even if you think your condition is better.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed 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 medication?

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 medication?

Tell your doctor or health care professional if your ear infection does not get better in a few days. This medicine is not for long-term use. Do not use for longer than directed without checking with your doctor or health care professional. Do not use if there is any discharge from the ear.

If rash or allergic reaction occurs, stop using this product immediately and contact your doctor or health care professional.

It is important that you keep the infected ear(s) clean and dry. When bathing, try not to get the infected ear(s) wet. Do not go swimming unless your doctor or health care professional has told you otherwise.

To prevent the spread of infection, do not share ear products or share towels and washcloths with anyone else.

What side effects may I notice from receiving this medication?

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

• burning, itching, rash, redness, swelling, or pain in the ear

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

• dry skin at the site of use

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 medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Keep tightly closed. 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.