Generic Name and Formulations:
Fluocinolone acetonide 0.01%; topical oil; contains peanut oil.
Hill Dermaceuticals, Inc
Indications for DERMA-SMOOTHE/FS:
Atopic dermatitis. Scalp psoriasis.
Atopic dermatitis: apply thin film to affected areas 3 times daily. Scalp psoriasis: apply a thin film to wet scalp, massage well, cover with shower cap. Leave on overnight or for at least 4 hours, then wash and rinse hair.
Atopic dermatitis: <3months: not recommended. ≥3months: moisten skin and apply a thin film to affected areas twice daily for up to 4 weeks.
Do not use superpotent forms on face, groin, or axillae. Exclude viral disease (eg, chickenpox, measles).
Treat infection if present; discontinue if infection persists or worsens. Do not use near eyes, or on diaper dermatitis or pre-existing skin atrophy. Do not use fluorinated steroids longer than 1 week on the face. Avoid abrupt cessation in chronic use. Systemic absorption increased by broken or inflamed skin, prolonged use, application to large surface area, or use of occlusive dressings. Occlude only if necessary; do not occlude higher potency products. Monitor adrenal function in children if a high potency product or occlusion is used, and in adults if more than 50g weekly of a high potency product is used. Discontinue or reduce dose or potency if HPA axis suppression, Cushing's syndrome, hyperglycemia, glucosuria, or irritation occurs. Use lowest effective dose and potency (esp. in children). Use caution if applying to face or body folds. Do not use continuously or for prophylaxis. Foams are flammable. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.
Burning, stinging, pruritus, erythema, skin atrophy, striae, miliaria, secondary infections, hypopigmentation, folliculitis, hypertrichosis, acneiform eruptions, dermal cracking and fissuring, telangiectasia, contact dermatitis, other local effects, immunosuppression, masks infections, HPA axis suppression (esp. in children).
Body Oil—4 oz; Scalp Oil—4oz