Fluocinolone Acetonide (floo-oh-SIN-oh-lone a-SEET-oh-nide)

Treats itchiness, swelling, and flaking skin of the external ear canal associated with chronic eczematous external otitis. This medicine is a steroid.

Brand Name(s):

DermOtic Oil, Flac Otic Oil

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Drop

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use this medicine only in your ear. Do not use this medicine on your face, especially in your eyes. In case of contact, wash eyes with water.
• Wash your hands with soap and water before and after using this medicine.
• Remove the cap. Do not let the tip of the dropper touch anything, including your ear.
• Lie down or tilt your head to the side. For a child, gently pull the child's earlobe down and back to straighten the child's ear canal. For an adult, gently pull the earlobe up and back to straighten the ear canal.
• Drop the prescribed number of drops into the ear. Keep the ear tilted up for a few minutes or put a cotton ball into your ear.
• Do not rinse the dropper.
• Do not cover the treated area with a dressing or bandage unless your doctor tells you to.

If a dose is missed:

• Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast-feeding, or if you have other ear infections.
• This product contains refined peanut oil, tell your doctor if you have had an allergic reaction to peanuts.
• Call your doctor if your symptoms do not improve or if they get worse.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Extreme weakness, tiredness, or confusion.
• Fever or chills.
• Gaining weight around your neck, upper back, breast, face, or waist.
• Increase in how much or how often you urinate.
• Increased thirst.
• Severe headache, or changes in vision.

If you notice these less serious side effects, talk with your doctor:

• Acne-like skin changes.
• Irritation, burning or itching in the ear.
• Skin rash or redness.
• Thinning of skin or dryness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088