Derma-Smoothe/FS (Body Oil)

Generic name: Fluocinolone Topical Oil

Usage of Derma-Smoothe/FS (Body Oil)

Fluocinolone topical (for the skin) is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Fluocinolone body oil is used to treat atopic dermatitis (a form of eczema). Fluocinolone scalp oil is used to treat scalp psoriasis.

Derma-Smoothe/FS (Body Oil) may also be used for purposes not listed in this medication guide.

Derma-Smoothe/FS (Body Oil) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing Derma-Smoothe/FS (Body Oil) through your skin, such as:

blurred vision, headache;

thinning skin, easy bruising;

mood changes;

weight gain, puffiness in your face; or

muscle weakness, feeling tired.

Common side effects of Derma-Smoothe/FS (Body Oil) may include:

mild skin itching, burning, dryness, or other irritation;

temporary hair loss;

swollen hair follicles;

blisters, pimples, or crusting of treated skin;

changes in color of treated skin;

skin rash or irritation around your mouth;

fever, cough, sore throat, runny or stuffy nose; or

red spots or the appearance of tiny veins (especially around your nose, cheeks, or chin).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Derma-Smoothe/FS (Body Oil)

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

To make sure Derma-Smoothe/FS (Body Oil) is safe for you, tell your doctor 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. It is not known whether Derma-Smoothe/FS (Body Oil) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether fluocinolone topical oil passes into breast milk or if it could harm a nursing baby. Do not apply this medication to your chest area if you are breast-feeding a baby.

Children can absorb larger amounts of this medication through the skin and may be more likely to have 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 to use Derma-Smoothe/FS (Body Oil)

Follow all directions on your prescription label. Do not use Derma-Smoothe/FS (Body Oil) in larger or smaller 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 Derma-Smoothe/FS (Body 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 Derma-Smoothe/FS (Body Oil).

To treat atopic dermatitis, moisten the skin and apply Derma-Smoothe/FS (Body 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 Derma-Smoothe/FS (Body 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, Derma-Smoothe/FS (Body Oil) may be applied twice daily for up to 4 weeks or until your symptoms disappear.

When treating scalp psoriasis, Derma-Smoothe/FS (Body 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.

Call your doctor if your symptoms do not improve within 2 weeks of treatment, if your symptoms get worse, or if you develop signs of a skin infection while using Derma-Smoothe/FS (Body Oil).

If you use this medication long-term, you may need frequent medical tests at your doctor's office.

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

Warnings

Do not use Derma-Smoothe/FS (Body Oil) 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.

This medication contains peanut oil. Tell your doctor if you have a peanut allergy.

Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects.

Call your doctor if your symptoms do not improve within 2 weeks of treatment, if your symptoms get worse, or if you develop signs of a skin infection while using Derma-Smoothe/FS (Body Oil).

What other drugs will affect Derma-Smoothe/FS (Body Oil)

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinolone. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Disclaimer

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