Derma-Smoothe Scalp/FS

DERMA-SMOOTHE Scalp/FS
(fluocinolone acetonide) Oil

For Topical Use Only
Not for Oral, Ophthalmic, or Intravaginal Use

DRUG DESCRIPTION

Derma-Smoothe/FS Topical® Oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(l-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® 0.01% fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for 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® 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 .

Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

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

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 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...

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

What are the precautions when taking fluocinolone acetonide (Derma-Smoothe Scalp/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...

Read All Potential Precautions of Derma-Smoothe Scalp/FS »

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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Derma-Smoothe Scalp/FS - User Reviews

Derma-Smoothe Scalp/FS User Reviews

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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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