Generic Name
Fluocinolone Acetonide
Brand Names
Derma-Smoothe, Dermotic, Flac, Iluvien, Neo-Synalar, Retisert, Synalar, YUTIQ
FDA approval date: June 11, 1963
Classification: Corticosteroid
Form: Ointment, Cream, Oil, Implant, Solution
What is Derma-Smoothe (Fluocinolone Acetonide)?
Derma-Smoothe/FS ® Scalp Oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults. DERMA-SMOOTHE/FS ® Scalp Oil is indicated for the treatment of psoriasis of the scalp in adults.
Approved To Treat
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Brand Information
DERMA-SMOOTHE/FS (fluocinolone acetonide)
1DOSAGE AND ADMINISTRATION
DERMA-SMOOTHE/FS Scalp Oil is for topical use only. Not for oral, ophthalmic, or intravaginal use.
Wet or dampen hair and scalp thoroughly. Apply a thin film of DERMA-SMOOTHE/FS Scalp Oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours then wash hair with regular shampoo and rinse thoroughly. Use daily as needed.
Discontinue DERMA-SMOOTHE/FS Scalp Oil when control of disease is achieved within 2 weeks, or contact the healthcare provider if no improvement is seen within 2 weeks.
Do not use DERMA-SMOOTHE/FS Scalp Oil on the face unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions
Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use.
2DOSAGE FORMS AND STRENGTHS
DERMA-SMOOTHE/FS Scalp Oil is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces and with 2 shower caps.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in more detail in other sections of the labeling:
4.1Clinical Studies Experience
Because clinical trials are conducted under widely varying condition, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of DERMA-SMOOTHE/FS Scalp Oil twice daily for 4 weeks. DERMA-SMOOTHE/FS Scalp Oil is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study:
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Endocrine Disorders:HPA axis suppression and Cushing’s syndrome
- Eye Disorders:glaucoma and cataracts
- Nervous System Disorders:intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema
5DESCRIPTION
DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil, 0.01% contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1–methylethylidene) bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C
Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of DERMA-SMOOTHE/FS Scalp Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil and fragrances.
Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.
DERMA-SMOOTHE/FS Scalp Oil is formulated with 48% refined peanut oil. The bulk refined peanut oil used in DERMA-SMOOTHE/FS Scalp Oil is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in DERMA-SMOOTHE/FS Scalp Oil is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm).
6CLINICAL STUDIES
In a vehicle-controlled study for the treatment of psoriasis of the scalp in adults, after 21 days of treatment, 60% of patients on active treatment and 21% of patients on the drug vehicle had excellent to cleared clinical response.
7HOW SUPPLIED / STORAGE AND HANDLING
DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil, 0.01% (NDC # 68791-102-04) is supplied in bottles containing 4 fluid ounces and with 2 shower caps.
8Principal Display Panel
PRINCIPAL DISPLAY PANEL - 118.28 mL Carton Label
NDC 68791-102-04
Rx only
Derma-Smoothe/FS®
Fluocinolone Acetonide
0.01% Topical Oil
0.01% Topical Oil
(SCALP OIL)
FOR TOPICAL USE ONLY
NOT FOR ORAL, OPHTHALMIC,
OR INTRAVAGINAL USE
OR INTRAVAGINAL USE
SHAKE WELL BEFORE USE
Net Contents 118.28 mL
(4 Fl. oz.)
(4 Fl. oz.)
ROYAL
PHARMACEUTICALS®
PHARMACEUTICALS®
