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|Chloroxylenol/Hydrocortisone/Pramoxine Solution

Chloroxylenol/Hydrocortisone/Pramoxine Solution

Chloroxylenol/Hydrocortisone/Pramoxine Solution is used for:

Treating certain infections of the outer ear canal that are complicated by inflammation. It is also used to control itching of the ear canal.

Chloroxylenol/Hydrocortisone/Pramoxine Solution is an antibacterial, steroid, and anesthetic combination. It works by killing bacteria, reducing inflammation, and temporarily relieving itching and pain.

Do NOT use Chloroxylenol/Hydrocortisone/Pramoxine Solution if:

• you are allergic to any ingredient in Chloroxylenol/Hydrocortisone/Pramoxine Solution
• you have chickenpox or vaccinia viral infection
• your eardrum is perforated

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

Before using Chloroxylenol/Hydrocortisone/Pramoxine Solution:

Some medical conditions may interact with Chloroxylenol/Hydrocortisone/Pramoxine 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 Chloroxylenol/Hydrocortisone/Pramoxine Solution. Because little, if any, of Chloroxylenol/Hydrocortisone/Pramoxine Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Chloroxylenol/Hydrocortisone/Pramoxine 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 Chloroxylenol/Hydrocortisone/Pramoxine Solution:

Use Chloroxylenol/Hydrocortisone/Pramoxine Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Chloroxylenol/Hydrocortisone/Pramoxine Solution is only for the ear. Do not get it in your eyes, nose, or mouth. If you get Chloroxylenol/Hydrocortisone/Pramoxine Solution in the eyes, flush thoroughly with cool water.
• Thoroughly clean and dry the outer ear before using Chloroxylenol/Hydrocortisone/Pramoxine Solution.
• 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 5 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 getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
• Wash your hands immediately after using Chloroxylenol/Hydrocortisone/Pramoxine Solution.
• If you miss a dose of Chloroxylenol/Hydrocortisone/Pramoxine 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 Chloroxylenol/Hydrocortisone/Pramoxine Solution.

Important safety information:

• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not use Chloroxylenol/Hydrocortisone/Pramoxine Solution for other conditions than the one for which it was prescribed.
• Chloroxylenol/Hydrocortisone/Pramoxine Solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Caution is advised when using Chloroxylenol/Hydrocortisone/Pramoxine Solution in CHILDREN; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Chloroxylenol/Hydrocortisone/Pramoxine Solution while you are pregnant. It is not known if Chloroxylenol/Hydrocortisone/Pramoxine Solution is found in breast milk. If you are or will be breast-feeding while you use Chloroxylenol/Hydrocortisone/Pramoxine Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Chloroxylenol/Hydrocortisone/Pramoxine Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Chloroxylenol/Hydrocortisone/Pramoxine Solution; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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.

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

General information:

• If you have any questions about Chloroxylenol/Hydrocortisone/Pramoxine Solution, please talk with your doctor, pharmacist, or other health care provider.
• Chloroxylenol/Hydrocortisone/Pramoxine 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 Chloroxylenol/Hydrocortisone/Pramoxine 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.