Derma-Smoothe/FS (Scalp)

Fluocinolone topical (for the skin) is a steroid. It lowers the effects of chemicals in the body that lead to 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 (Scalp) may also be used for reasons not mentioned in this medication guide.

Do not use Derma-Smoothe/FS (Scalp) 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 (Scalp).

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 (Scalp) 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 (Scalp) 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.

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 right away if you have severe irritation of any treated skin, or if you show signs of absorbing Derma-Smoothe/FS (Scalp) 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 (Scalp) 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.

Follow all directions on your prescription label. Do not use Derma-Smoothe/FS (Scalp) 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 (Scalp) 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 (Scalp).

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

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

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.

Use the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of Derma-Smoothe/FS (Scalp) is not expected to cause life-threatening symptoms. However, using high doses of steroids for a long time can result in symptoms like thinning skin, easy bruising, changes in body fat shape or location (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual issues, impotence, or loss of interest in sex.

Do not use Derma-Smoothe/FS (Scalp) to treat any skin issue that has not been evaluated by your doctor.

Avoid getting this medication in your eyes. If it does get in your eyes, rinse with water. Do not use Derma-Smoothe/FS (Scalp) on broken or infected skin, or in an open wound.

It is unlikely that other medications you take by mouth or inject will affect fluocinolone when it is applied to your skin. However, many medications can interact with each other. Inform all your health care providers about every medicine you use, including prescription and over-the-counter medicines, vitamins, and herbal products.