Fluocinolone is a steroid medicine.

Flac Otic Oil (for use in the ear) is used to treat eczema of the outer ear canal in adults and children at least 2 years old.

Flac Otic Oil may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Otic medicine is for use only in the ears.

Wash your hands before using ear drops.

To use the ear drops:

• Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.

• Hold the dropper upside down over your ear and drop the correct number of drops into the ear.

• Stay lying down or with your head tilted for about a minute.

• Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

To avoid getting this medicine on your face, use a clean cotton ball to wipe off any medicine that drains from your ear.

You should not plug the treated ear with cotton. Doing so could increase the risk of unwanted side effects.

Call your doctor if your symptoms do not improve after 2 weeks, or if your symptoms get worse.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

You should not use Flac Otic Oil if you are allergic to fluocinolone. This medicine contains peanut oil. Tell your doctor if you have a peanut allergy.

You may not be able to use this medicine if you have a skin infection.

Tell your doctor if you are pregnant or breastfeeding.

Flac Otic Oil should not be used on a child younger than 2 years old. Children can absorb larger amounts of this medicine through the skin.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

High doses or long-term use of steroid medicine can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Do not get Flac Otic Oil in your eyes. If contact does occur, rinse with water.

Do not use Flac Otic Oil to treat any condition that has not been checked by your doctor.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Flac Otic Oil may cause serious side effects. Stop using Flac Otic Oil and call your doctor at once if you have:

• severe irritation in or around your ear; or

• signs of a skin infection--warmth, redness, swelling, sores, oozing.

Your skin can absorb topical steroid medicine, which may cause steroid side effects throughout the body. Tell your doctor if you have:

• swelling, weight gain (especially in your face or your upper back and torso);

• thinning skin, stretch marks, acne, increased facial hair;

• memory problems, feeling irritable;

• irregular menstrual periods, changes in sexual function; or

• growth delay in a child.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Common side effects of Flac Otic Oil may include:

• burning, itching, irritation, or dryness;

• rash around the ear in which this medicine was applied;

• rash or irritation around your mouth;

• acne, pimples, stretch marks;

• lightened skin color; or

• redness or crusting around your hair follicles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.