Fluocinolone Acetonide Topical ointment

What is this medicine?

FLUOCINOLONE (floo oh SIN oh lone) is a corticosteroid. It is used on the skin to reduce swelling, redness, itching, and allergic reactions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any active infection
• diabetes
• large areas of burned or damaged skin
• skin wasting or thinning
• an unusual or allergic reaction to fluocinolone, steroids, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Apply a thin film of medicine to the affected area. Do not cover with a bandage or dressing unless your doctor or health care professional tells you to. Do not use on healthy skin or over large areas of skin. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. It is important not to use more medicine than prescribed. Do not use your medicine more often than directed. Do not use for more than 14 days.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply. If applying this medicine to the diaper area of a child, do not cover with tight-fitting diapers or plastic pants. This may increase the amount of medicine that passes through the skin and increase the risk of serious side effects.

Elderly patients are more likely to have damaged skin through aging, and this may increase side effects. This medicine should only be used for brief periods and infrequently in older patients.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other skin products without telling your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not improve within one week. Tell your doctor or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• burning or itching of the skin
• dark red spots on the skin
• infection
• lack of healing of skin condition
• painful, red, pus filled blisters in hair follicles
• thinning of the skin, sunburn more likely especially on the face

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dry skin, irritation
• unusual increased growth of hair on the face or body

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from heat and direct light. Do not freeze. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.