Source: FDA, National Drug Code (US) Revision Year: 2020
DermOtic Oil Ear Drops contain 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. This formulation is also marketed as Derma-Smoothe/FS Body Oil for the treatment of atopic dermatitis and Derma-Smoothe/FS Scalp Oil for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C24H30F2O6.
It has the following structural formula:
Fluocinolone acetonide in DermOtic Oil 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 DermOtic 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 NF and fragrances.
| How Supplied |
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DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net content (Dropper Included) (NDC # 68791-103-20). Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.)[see USP Controlled Room Temperature]. Discard DermOtic Oil 2 months after initial use. Manufactured by: Hill Dermaceuticals, Inc., Sanford, FL 32773 For: Royal Pharmaceuticals, Inc, Manasquan, NJ 08736 |
| Drug | Countries | |
|---|---|---|
| DERMOTIC | Canada, United States |
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