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Derma-Smoothe FS

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Derma-Smoothe/FS

Derma-Smoothe/FS®
(fluocinolone acetonide) Topical Oil, 0.01%
(Body Oil)

For topical use only

Derma-Smoothe/FS

DRUG DESCRIPTION

Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Body Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1- methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Scalp Oil) 0.01% fluocinolone acetonide for use with shower caps for treatment of scalp psoriasis in adults and as fluocinolone acetonide oil, 0.01% for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:

Derma-Smoothe/FS (fluocinolone acetonide) structural formula illustration

Fluocinolone acetonide in Derma-Smoothe/FS (fluocinolone acetonide) has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of Derma-Smoothe/FS contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances.

Derma-Smoothe/FS (fluocinolone acetonide) is formulated with 48% refined peanut oil NF. The peanut oil used in Derma-Smoothe/FS (fluocinolone acetonide) is tested for peanut proteins through amino acid analysis which can detect the quantity of amino acids to below 0.5 parts per million.

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...

Read All Potential Side Effects and See Pictures of Derma-Smoothe/FS »

What are the precautions when taking fluocinolone acetonide (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 peanuts), 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...

Read All Potential Precautions of Derma-Smoothe/FS »

Last reviewed on RxList: 1/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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Derma-Smoothe/FS - User Reviews

Derma-Smoothe/FS User Reviews

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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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