Derma-Smoothe / FS (Body Oil)

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

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 purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

You should not use fluocinolone topical oil on your face, underarms, or groin area unless your doctor has told you to. Avoid applying this medication to areas where the skin creases.

Wash your hands before and after using fluocinolone topical oil.

To treat atopic dermatitis, moisten the skin and apply fluocinolone topical oil in a thin film. Rub gently into the skin. Use only enough oil to cover the affected skin. Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to.

To treat scalp psoriasis, apply fluocinolone topical oil at bedtime. Wet or dampen the hair and scalp thoroughly and apply the medicine directly to the scalp in a thin film. Massage it in well and cover your scalp with the supplied shower cap. Leave the medication on overnight or for at least 4 hours. Wash and thoroughly rinse your hair with regular shampoo the next morning.

If you prefer not to wash your hair every day, you may still use fluocinolone oil daily between washings. Simply apply the medication without wetting the hair and massage gently into the scalp. Leave the medication on your scalp for at least 4 hours, then rinse thoroughly.

When treating atopic dermatitis, fluocinolone topical oil may be applied twice daily for up to 4 weeks or until your symptoms disappear.

When treating scalp psoriasis, fluocinolone topical oil may be used daily until your symptoms improves. Then you may continue using the medication once per week, or often enough to keep the skin soft and free from scales or crusting.

Call your doctor if your symptoms do not improve within 2 weeks of treatment, if your symptoms get worse, or if you develop signs of a skin infection while using fluocinolone topical oil.

If you use this medication long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Applies to fluocinolone topical: compounding powder, topical cream, topical kit, topical lotion, topical oil, topical ointment, topical shampoo, topical solution

General

The most commonly reported side effects were erythema, itching, irritation, and burning.[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Immunologic

Common (1% to 10%): Facial herpes simplex, abscess, molluscum[Ref]

Local

Common (1% to 10%): Telangiectasia, erythema, itching, irritation, burning, hypopigmentation, hyperpigmentation, shiny skin, folliculitis, acneiform eruptions[Ref]

Nervous system

Frequency not reported: Intracranial hypertension (including bulging fontanelles, headaches, bilateral papilledema)

Dermatologic

Common (1% to 10%): Secondary atopic dermatitis, papules and pustules, keratosis pilaris, eczema, rash
Frequency not reported: Hypertrichosis, maceration of the skin, dermatitis, perioral dermatitis, acne or worsening of acne, acne rosacea[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Some side effects of Derma-Smoothe / FS (Body Oil) may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Topical (body) oil: Apply a thin film to the affected areas three times a day

Comments:
-Use should be discontinued when control of disease is achieved.
-If no improvement is seen within 2 weeks, a healthcare provider should be contacted.

Use: Treatment of atopic dermatitis

Apply a thin film to the affected area two to four times a day

Comments:
-Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
-If an infection occurs, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Safety and efficacy in pediatric patients younger than 3 months of age have not been established.

Consult WARNINGS section for additional precautions.

Data not available

Administration advice:
-This drug should not be used on the face, groin, or axillae, unless directed by a healthcare professional.
-The treated area should not be bandaged, covered, or wrapped, as to be occlusive, unless directed by a healthcare provider.
-Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area.

Storage requirements:
-Excessive heat and freezing should be avoided.

Monitoring:
-Endocrine: HPA-axis suppression (Urinary free-cortisol test, ACTH-stimulation test)

Patient advice:
-Patients should report any signs of local adverse reactions, especially those that develop under occlusive dressings.
-This medication is to be used as directed by the physician. It is for external use only. Contact with the eyes should be avoided.
-Patients should be advised not to use this medication for any condition other than for which it was prescribed.