Flac Otic (ear) Oil 0.01 % drops

Generic name:
Fluocinolone oil - otic

Pronunciation
(FLOO-oh-SIN-oh-lone)

Brand name(s)
Dermotic

This medication is used to treat eczema of the outer ear (also known as chronic itchy ear). The main symptom is itchiness, but redness, flaking, or oozing may also occur. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal as directed by your doctor, usually twice a day. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted for about 1 minute, or insert a soft cotton plug if so directed. Remove the plug after 1 minute. Repeat for the other ear if so directed. Do not rinse the dropper. Replace the cap after use. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.

Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.

Dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Tell your doctor if your condition lasts or gets worse after 2 weeks.

Stinging, burning, irritation, dryness, or redness at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Tell your doctor promptly if redness, swelling, or irritation does not improve.

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

It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.