Derma-Smoothe/FS® Body Oil

Indications and Usage

Derma-Smoothe/FS^® Body Oil is a corticosteroid for:

• topical treatment of atopic dermatitis/eczema in adult patients
• topical treatment of moderate to severe atopic dermatitis/eczema in patients 3 months and older for up to 4 weeks

Dosage and Administration

Derma-Smoothe/FS^® Body Oil is not for oral, ophthalmic, or intravaginal use.

Adult patients

Apply to affected areas 3 times daily.

Pediatric patients

Moisten skin and apply to affected areas twice daily for up to 4 weeks.

Important Safety Information

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 cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).

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® Body Oil is right for you.

 Full Prescribing Information