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fluocinolone topical (oil) (cont.)

What should I discuss with my healthcare provider before using fluocinolone topical oil (Derma-Smoothe/FS)?

Do not use this medication if you are allergic to fluocinolone. This medication contains peanut oil. Tell your doctor if you have a peanut allergy.

Before using fluocinolone topical oil, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether fluocinolone topical oil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

How should I use fluocinolone topical oil (Derma-Smoothe/FS)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

You should not use fluocinolone topical oil on your face, underarms, or groin area unless your doctor has told you to. Avoid applying this medication to areas where the skin creases.

Wash your hands before and after using fluocinolone topical oil.

To treat atopic dermatitis, moisten the skin and apply fluocinolone topical oil in a thin film. Rub gently into the skin. Use only enough oil to cover the affected skin. Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to.

To treat scalp psoriasis, apply fluocinolone topical oil at bedtime. Wet or dampen the hair and scalp thoroughly and apply the medicine directly to the scalp in a thin film. Massage it in well and cover your scalp with the supplied shower cap. Leave the medication on overnight or for at least 4 hours. Wash and thoroughly rinse your hair with regular shampoo the next morning.

If you prefer not to wash your hair every day, you may still use fluocinolone oil daily between washings. Simply apply the medication without wetting the hair and massage gently into the scalp. Leave the medication on your scalp for at least 4 hours, then rinse thoroughly.

When treating atopic dermatitis, fluocinolone topical oil may be applied twice daily for up to 4 weeks or until your symptoms disappear.

When treating scalp psoriasis, fluocinolone topical oil may be used daily until your symptoms improves. Then you may continue using the medication once per week, or often enough to keep the skin soft and free from scales or crusting.

Contact your doctor if your condition does not improve after 2 weeks of use, if it gets worse, or if you develop signs of a skin infection.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

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

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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