SPL Set ID: bc61c619-a71c-46f5-80f1-9e9ee71134aa

1 drug(s) with this SPL Set ID

Open DailyMed details

Derma-Smoothe/FS FLUOCINOLONE ACETONIDE
ROYAL PHARMACEUTICALS FDA Rx Only

Derma-Smoothe/FS ® (fluocinolone acetonide), Topical Oil, 0.01% (Body Oil) 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. This formulation is also marketed as Derma-Smoothe/FS ® (fluocinolone acetonide), Topical Oil, 0.01% (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults, and as fluocinolone acetonide oil, 0.01% for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in Derma-Smoothe/FS ® 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 ® 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 NF and fragrances. Derma-Smoothe/FS ® is formulated with 48% refined peanut oil NF. The peanut oil used in Derma-Smoothe/FS ® is tested for peanut proteins through amino acid analysis which can detect the quantity of amino acids to below 0.5 parts per million. Chemical Structure

← Back to search