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Derma-smoothe/fs Generic Name & Formulations
Legal Class
Rx
General Description
Fluocinolone acetonide 0.01%; topical oil; contains peanut oil.
How Supplied
Body Oil—4 oz
Manufacturer
Generic Availability
YES
Derma-smoothe/fs Indications
Indications
Atopic dermatitis.
Limitations of Use
Apply the least amount to cover affected areas. Do not use on face, groin, or axillae. Do not use on diaper area. Discontinue when disease is controlled.
Derma-smoothe/fs Dosage and Administration
Adult
Apply thin film to affected areas 3 times daily.
Children
<3months: not recommended. ≥3months: moisten skin and apply a thin film to affected areas twice daily for up to 4 weeks.
Derma-smoothe/fs Contraindications
Not Applicable
Derma-smoothe/fs Boxed Warnings
Not Applicable
Derma-smoothe/fs Warnings/Precautions
Warnings/Precautions
Treat infection if present; discontinue if infection persists or worsens. 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. Do not use continuously or for prophylaxis. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.
Derma-smoothe/fs Pharmacokinetics
See Literature
Derma-smoothe/fs Interactions
Not Applicable
Derma-smoothe/fs Adverse Reactions
Adverse Reactions
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).
Derma-smoothe/fs Clinical Trials
See Literature
Derma-smoothe/fs Note
Not Applicable
Derma-smoothe/fs Patient Counseling
See Literature
Derma-smoothe/fs Generic Name & Formulations
Legal Class
Rx
General Description
Fluocinolone acetonide 0.01%; topical oil; contains peanut oil.
How Supplied
Scalp Oil—4 oz
Manufacturer
Generic Availability
YES
Derma-smoothe/fs Indications
Indications
Scalp psoriasis.
Limitations of Use
Apply the least amount to cover affected areas. Do not use on face, groin, or axillae. Discontinue when disease is controlled.
Derma-smoothe/fs Dosage and Administration
Adult
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.
Children
Not recommended.
Derma-smoothe/fs Contraindications
Not Applicable
Derma-smoothe/fs Boxed Warnings
Not Applicable
Derma-smoothe/fs Warnings/Precautions
Warnings/Precautions
Treat infection if present; discontinue if infection persists or worsens. 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. Do not use continuously or for prophylaxis. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.
Derma-smoothe/fs Pharmacokinetics
See Literature
Derma-smoothe/fs Interactions
Not Applicable
Derma-smoothe/fs Adverse Reactions
Adverse Reactions
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).
Derma-smoothe/fs Clinical Trials
See Literature
Derma-smoothe/fs Note
Not Applicable
Derma-smoothe/fs Patient Counseling
See Literature
