Aluminum Acetate Shampoo, Fluocinolone Acetonide Concentrate for topical solution

What is this medicine?

FLUOCINOLONE (floo oh SIN oh lone) is a corticosteroid. It is used to treat skin problems of the scalp that may cause itching and swelling.

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, aluminum acetate, corticosteroids, 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. Shake well before using. Apply the shampoo to the scalp and work into a lather. Leave on the scalp for about 5 minutes unless your doctor or health care professional tells you differently. Then, rinse your hair and scalp thoroughly to remove the shampoo. Do not use your medicine more often than directed or for a longer period of time than ordered by your doctor or health care professional. To do so may increase the chance of absorption through the skin and the chance of side effects. Do not bandage or cover the treated scalp area unless directed to do so by your doctor or health care professional. Do not get the shampoo in your eyes. If you do, rinse it out with plenty of cool tap water.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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 scalp 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 get better 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:

• any active infection
• dark red spots on the skin
• lack of healing of the skin condition
• painful, red, pus filled blisters in hair follicles
• severe burning and continued itching of the skin
• thinning of the skin with easy bruising

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

• burning, itching, or irritation of the skin
• dry skin
• increased redness or scaling of the skin

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) away from heat and direct light. Do not freeze. Throw away any remaining shampoo after three months.

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.