Drugs Similar to FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

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Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
COSETTE PHARMACEUTICALS, INC. FDA Rx Only

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24 H 30 F 2 0 6 , a molecular weight of 452.49 and the following structural formula: Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP. Chemical Structure

Fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide 0.01% Solution (each mL contains 0.1 mg Fluocinolone Acetonide) in a water-washable base containing citric acid and propylene glycol. Chemical Structure

fluocinolone acetonide FLUOCINOLONE ACETONIDE
ANI PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax. Structure

Fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
ANI PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Ointment USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a white petrolatum USP vehicle. Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

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 Fluocinolone acetonide topical oil, 0.01% (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in fluocinolone acetonide topical 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 fluocinolone acetonide topical 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, and refined peanut oil. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide 0.01% Topical Oil for peanut-sensitive individuals. Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. FDA Rx Only

Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of C 24 H 30 F 2 O 6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum. chemical structure

fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (Ear Drops) 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals. Structural Formula

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide oil, 0.01% (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 fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. 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 fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
QUAGEN PHARMACEUTICALS LLC FDA Rx Only

Fluocinolone acetonide oil, 0.01% (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 fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. 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 fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. structure

Fluocinolone acetonide FLUOCINOLONE ACETONIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Fluocinolone Acetonide Topical Oil, 0.01% (Scalp 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. 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 Fluocinolone Acetonide Topical Oil, 0.01% (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 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes. Chemical Structure

fluocinolone acetonide FLUOCINOLONE ACETONIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

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. 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 Fluocinolone Acetonide Topical Oil, 0.01% (Body 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 and refined peanut oil. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes. Structural Formula

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
QUAGEN PHARMACEUTICALS LLC FDA Rx Only

Fluocinolone acetonide topical oil, 0.01% (scalp 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 fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. 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 fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (ear drops) 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 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 fluocinolone acetonide topical oil, 0.01% (body 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 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide topical oil, 0.01% (scalp 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 fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. 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 fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
COSETTE PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Cream, USP 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Cream, USP contains fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, simethicone emulsion, stearyl alcohol, and white wax. FA Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
FOUGERA PHARMACEUTICALS INC. FDA Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide USP (Pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-); it has an empirical formula of C 24 H 30 F 2 O 6 and a molecular weight of 425.49. Each mL of the topical solution contains 0.1 mg fluocinolone acetonide in a water-washable base containing propylene glycol and citric acid. chemical-structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
LUPIN PHARMACEUTICALS,INC. FDA Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water washable base of citric acid and propylene glycol. Chemical Structure

fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (Ear Drops) 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals.

By Generic Name

Drugs with the same generic name (different brands)

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

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

DERMOTIC FLUOCINOLONE ACETONIDE
ROYAL PHARMACEUTICALS FDA Rx Only

DERMOTIC OIL (fluocinolone acetonide) 0.01% ear drops contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16, 17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene3,20-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 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 and fragrances. DERMOTIC OIL is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in DERMOTIC OIL is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in DERMOTIC 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

Flac Otic Oil FLUOCINOLONE ACETONIDE
PATRIN PHARMA, INC. FDA Rx Only

Flac ® 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 fluocinolone acetonide oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide oil, 0.01% (scalp oil) for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide Oil, 0.01% 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 fluocinolone acetonide oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide 0.01% Solution (each mL contains 0.1 mg Fluocinolone Acetonide) in a water-washable base containing citric acid and propylene glycol. Chemical Structure

Fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Chemical Structure

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
COSETTE PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Cream, USP 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Cream, USP contains fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, simethicone emulsion, stearyl alcohol, and white wax. FA Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
COSETTE PHARMACEUTICALS, INC. FDA Rx Only

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24 H 30 F 2 0 6 , a molecular weight of 452.49 and the following structural formula: Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP. Chemical Structure

fluocinolone acetonide FLUOCINOLONE ACETONIDE
ANI PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax. Structure

Fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
QUAGEN PHARMACEUTICALS LLC FDA Rx Only

Fluocinolone acetonide topical oil, 0.01% (scalp 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 fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. 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 fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
ANI PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Ointment USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a white petrolatum USP vehicle. Structure

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide oil, 0.01% (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 fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. 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 fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide oil, 0.01% (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 fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. 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 fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.

fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (Ear Drops) 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals. Structural Formula

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (ear drops) 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 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 fluocinolone acetonide topical oil, 0.01% (body 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 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide topical oil, 0.01% (scalp 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 fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. 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 fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
LUPIN PHARMACEUTICALS,INC. FDA Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water washable base of citric acid and propylene glycol. Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (ear drops) 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 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 fluocinolone acetonide topical oil, 0.01% (body 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 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. FDA Rx Only

Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of C 24 H 30 F 2 O 6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum. chemical structure

By Substance

Drugs sharing the same substance name

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

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

DERMOTIC FLUOCINOLONE ACETONIDE
ROYAL PHARMACEUTICALS FDA Rx Only

DERMOTIC OIL (fluocinolone acetonide) 0.01% ear drops contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16, 17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene3,20-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 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 and fragrances. DERMOTIC OIL is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in DERMOTIC OIL is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in DERMOTIC 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

Flac Otic Oil FLUOCINOLONE ACETONIDE
PATRIN PHARMA, INC. FDA Rx Only

Flac ® 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 fluocinolone acetonide oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide oil, 0.01% (scalp oil) for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide Oil, 0.01% 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 fluocinolone acetonide oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Fluocinolone acetonide Scalp 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. This formulation is also marketed as Fluocinolone Acetonide, 0.01% for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinolone acetonide oil, 0.01% for 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 fluocinolone acetonide scalp oil, 0.01% 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 fluocinolone acetonide 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 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. FDA Rx Only

Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of C 24 H 30 F 2 O 6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum. chemical structure

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
QUAGEN PHARMACEUTICALS LLC FDA Rx Only

Fluocinolone acetonide oil, 0.01% (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 fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. 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 fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide topical oil, 0.01% (scalp 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 fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. 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 fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (Ear Drops) 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide topical oil, 0.01% (scalp 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 fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. 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 fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide 0.01% Solution (each mL contains 0.1 mg Fluocinolone Acetonide) in a water-washable base containing citric acid and propylene glycol. Chemical Structure

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
COSETTE PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Cream, USP 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Cream, USP contains fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, simethicone emulsion, stearyl alcohol, and white wax. FA Chemical Structure

fluocinolone acetonide FLUOCINOLONE ACETONIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

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. 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 Fluocinolone Acetonide Topical Oil, 0.01% (Body 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 and refined peanut oil. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes. Structural Formula

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

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 Fluocinolone acetonide topical oil, 0.01% (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in fluocinolone acetonide topical 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 fluocinolone acetonide topical 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, and refined peanut oil. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide 0.01% Topical Oil for peanut-sensitive individuals. Chemical Structure

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
LUPIN PHARMACEUTICALS,INC. FDA Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water washable base of citric acid and propylene glycol. Chemical Structure

fluocinolone acetonide FLUOCINOLONE ACETONIDE
ANI PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax. Structure

Fluocinolone acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for 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 Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

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 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% (ear drops) 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 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 fluocinolone acetonide topical oil, 0.01% (body 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 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF.

Fluocinolone Acetonide FLUOCINOLONE ACETONIDE
ANI PHARMACEUTICALS, INC. FDA Rx Only

Fluocinolone Acetonide Ointment USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a white petrolatum USP vehicle. Structure

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE
BRYANT RANCH PREPACK FDA Rx Only

Fluocinolone acetonide oil, 0.01% (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 fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. 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 fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.

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