SPL Set ID: 113e167a-a9fe-440e-9446-d6d87963ef46

1 drug(s) with this SPL Set ID

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DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE
ROYAL PHARMACEUTICALS FDA Rx Only

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 24 H 30 F 2 O 6 . It has the following structural formula: 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). Chemical Structure

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