Derma-Smoothe/FS® Scalp Oil

Indications and Usage

Derma-Smoothe/FS^® Scalp Oil is a low to medium potency corticosteroid indicated:

• In adult patients for psoriasis of the scalp.

Dosage and Administration

Derma-Smoothe/FS^® Oil for scalp psoriasis in adults (Scalp Oil).

For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Derma-Smoothe/FS^® on the scalp, massage well and cover scalp with the supplied shower cap.  Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.

Important Safety Information

Contraindications

• Patients with hypersensitivity to Derma-Smoothe/FS Scalp Oil or its ingredients.

Warnings & Precautions

• Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria.
• Because of the potential for systemic absorption, use of topical corticosteroids may require evaluation for HPA axis suppression.  Potent corticosteroids, use on large areas, prolonged use, or occlusive use may increase systemic absorption.  If HPA axis suppression develops, modify treatment.
• Local adverse reactions may occur with topical corticosteroids, including atrophy, striae, acneiform eruptions, hypopigmentation, and allergic contact dermatitis, and may be more likely with occlusive use or more potent corticosteroids.
• Children may be more susceptible to systemic toxicity from equivalent doses.

The most common adverse reactions (> 5%) were telegiectasia (9%), erythema (5%), itching (5%), irritation (5%), and burning (5%).

Derma-Smoothe/FS is for topical use only; not for oral, ophthalmic, or vaginal use.

This safety information is not comprehensive. Please see Full Prescribing Information.  Ask your healthcare provider if Derma-Smoothe/FS® Scalp Oil is right for you.

 Full Prescribing Information