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Brand Names: Derma-Smoothe/FS

Generic Name: fluocinolone topical (oil) (Pronunciation: floo oh SIN oh lone TOP i kal)

• What is fluocinolone topical oil (Derma-Smoothe/FS)?
• What are the possible side effects of fluocinolone topical oil (Derma-Smoothe/FS)?
• What is the most important information I should know about fluocinolone topical oil (Derma-Smoothe/FS)?
• What should I discuss with my healthcare provider before using fluocinolone topical oil (Derma-Smoothe/FS)?
• How should I use fluocinolone topical oil (Derma-Smoothe/FS)?
• What happens if I miss a dose (Derma-Smoothe/FS)?
• What happens if I overdose (Derma-Smoothe/FS)?
• What should I avoid while using fluocinolone topical oil (Derma-Smoothe/FS)?
• What other drugs will affect fluocinolone topical oil (Derma-Smoothe/FS)?
• Where can I get more information?

What is fluocinolone topical oil (Derma-Smoothe/FS)?

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

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

Fluocinolone topical oil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluocinolone topical oil (Derma-Smoothe/FS)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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 fluocinolone topical 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.

Less serious side effects 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about 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.

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

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.

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.