Drug Information

Derma-Smoothe-Fs

What is DERMA-SMOOTHE-FS?

(DERMA-SMOOTHE-FS) This medication is used to treat eczema, a skin condition which causes red, irritated, and itchy skin. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

How should I use DERMA-SMOOTHE-FS?

Shake well before each use. Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor. Do not apply this medication to the diaper area. Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in, usually 3 times daily or as directed by your doctor. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. After applying the medication, wash your hands unless you are using this medication to treat the hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water. Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed. Inform your doctor if your condition persists or worsens after 2 weeks.

What should I tell my health care provider before I take DERMA-SMOOTHE-FS?

Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve. Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

What may interact with DERMA-SMOOTHE-FS?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: other corticosteroids (e.g., hydrocortisone, prednisone).

What if I miss a dose of DERMA-SMOOTHE-FS?

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

What side effects may I notice from receiving DERMA-SMOOTHE-FS?

Stinging, burning, irritation, dryness, or redness at the application site may occur. Acne, excessive hair growth, "hair bumps" (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep DERMA-SMOOTHE-FS?

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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