Cortane-B Aqueous otic

Chloroxylenol is an antibiotic that treats infections caused by bacteria or fungus.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Pramoxine is a topical anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Chloroxylenol, hydrocortisone, and pramoxine otic (for the ear) is a combination medicine used to treat infections in the ear canal, and to relieve the symptoms of itching or swelling. This medicine will not treat an inner ear infection (also called otitis media).

Medicinal use of this product to treat ear infections has not been approved by the FDA. Chloroxylenol, hydrocortisone, and pramoxine otic should not be used in place of medication prescribed for you by your doctor.

Chloroxylenol, hydrocortisone, and pramoxine may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to chloroxylenol, hydrocortisone, or pramoxine or if you have:

• a hole in your ear drum (ruptured ear drum); or

• chickenpox or cowpox.

To make sure this medicine is safe for you, tell your doctor if you have:

• an inner ear infection;

• severe ear pain;

• hearing problems; or

• fever.

It is not known whether chloroxylenol, hydrocortisone, and pramoxine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice. Children can absorb larger amounts of this medicine through the ear canal and may be more likely to have side effects.

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.

An overdose of this medicine is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Before using this medication, tell your doctor or pharmacist if you are allergic to hydrocortisone, chloroxylenol, or pramoxine; or to other corticosteroids (e.g., betamethasone); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a hole in the eardrum (ruptured tympanic membrane), certain viral infections (vaccinia, chickenpox).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear surgery/injury, infection/swelling of the middle ear.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.