Derma-Smoothe Scalp/FS

DRUG DESCRIPTION

Derma-Smoothe/FS® Topical Oil contains fluocinolone acetonide {(6a, 11b, 16a)-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® 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 fluocinone acetonide oil, 0.01%for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24 H30 F2 O6. It has the following structural formula:

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.

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)?

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
  • ...

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 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 Scalp/FS »


Derma-Smoothe Scalp/FS Consumer (continued)

SIDE EFFECTS: 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 your doctor has prescribed this medication because he or she 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, seek immediate medical attention 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 respond to physical stress. Therefore, 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 slow down a child's growth if used for a long time. The effect on final adult height is unknown. 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.


Derma-Smoothe Scalp/FS Patient Information Including Side Effects

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

What is fluocinolone topical oil (Derma-Smoothe Scalp/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 Scalp/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 Scalp/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.

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