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.

Fluocinolone Acetonide Implant tablet

What is this medicine?

FLUOCINOLONE INTRAVITREAL IMPLANT (floo oh SIN oh lone) is a corticosteroid. It is surgically placed in the eye to help treat swelling in the eye or diabetic macular edema.

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

• an unusual or allergic reaction to fluocinolone, other corticosteroids, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

The implant is surgically placed in the eye by a doctor. After the surgery, you should have regular follow up exams of both eyes.

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?

This does not apply.

What may interact with this medicine?

Interactions are not expected. Do not use any other eye 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?

Visit your doctor or health care professional for regular checks on your progress. You will need to have your affected eye checked regularly following surgery.

Make sure to follow all of the instructions given to you by your health care provider after your surgery.

After surgery, you will most likely experience an immediate, but temporary, decrease in vision in the affected eye. This is likely a result of the procedure and should get better within one to four weeks. Contact your doctor or health care professional if your vision loss lasts longer than one month.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• eye pain, decreased or blurred vision that does not go away within a month of surgery

• sign of infection in the eye

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

• eye irritation, redness, swelling

• watery eyes

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?

The implant is only used during surgery. You will not store this medicine at home.

Fluocinolone Acetonide Otic drops, oil

What is this medicine?

FLUOCINOLONE (floo oh SIN oh lone) is a corticosteroid. It is used to reduce swelling, redness, and itching of the ear.

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

• an unusual or allergic reaction to fluocinolone, corticosteroids, peanut allergy, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the ears. Wash your hands with soap and water. Do not insert any object or swab into the ear canal. Gently warm the bottle by holding it in your hand for 1 to 2 minutes. Lie down on your side with the affected ear up. Try not to touch the tip of the dropper to your ear, fingertips, or other surface. Squeeze the container gently to put the prescribed number of drops in the ear canal. Stay in this position for 60 seconds to help the drops soak into the ear. Repeat the steps for the other ear if both ears are infected. Do not use your medicine more often than directed. Finish the full course of medicine prescribed by your doctor or health care professional even if you think your condition is better.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Overdosage: If you think you've 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 ear 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 healthcare professional if your symptoms do not start to get better or if they get worse.

It is important that you keep the ear(s) clean and dry. When bathing, try not to get the ear(s) wet. Do not go swimming unless your doctor or health care professional has told you otherwise.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• burning or itching of the ear

• ear pain that gets worse

• infection

• lack of healing of ear condition

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

• abnormal feeling in the ear

• dry skin, irritation

• unpleasant feeling while putting the drops in the ear

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 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Fluocinolone Acetonide Shampoo

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, 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 two 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.

Fluocinolone Acetonide Topical cream

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.

Fluocinolone Acetonide Topical oil

What is this medicine?

FLUOCINOLONE (floo oh SIN oh lone) is a corticosteroid. It is used to treat skin problems 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 type of active infection

• diabetes

• large areas of burned or damaged skin

• skin wasting or thinning

• an unusual or allergic reaction to fluocinolone, steroids, other medicines, peanuts, 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. Do not use this 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 side effects. Do not use on healthy skin or over large areas of skin. Do not get this medicine in your eyes. If you do, rinse it out with plenty of cool tap water.

For areas other than the scalp- Apply a thin film of oil to the affected area and rub in gently. Do not bandage or wrap the skin being treated unless directed to do so by your doctor or health care professional.

For use on the scalp- Wet or dampen your hair and scalp before using this medicine. Apply a thin film of oil, massage well, and cover your scalp with the shower cap provided. Leave on overnight or for at least 4 hours before washing off unless you are given different instructions from your doctor or health care professional. Then, wash your hair with regular shampoo and rinse completely.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 months of age for selected conditions, precautions do apply.

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 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:

• 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

• 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) away from heat and direct light. Do not freeze. Throw away any unused medicine after the expiration date.

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.

Fluocinolone Acetonide Topical solution

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.