Fluocinonide

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

The topical corticosteriods are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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History

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Other Information

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula:

C26H32F207 M.W. 494.54

Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water.

Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties.

In this formulation, the active ingredient is totally in solution.

Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment.

In this formulation, the active ingredient is totally in solution.

Sources

Fluocinonide Manufacturers

Teva Pharmaceuticals Usa Inc

Fluocinonide | Teva Pharmaceuticals Usa Inc

The topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Stat Rx Usa Llc

Fluocinonide | Stat Rx Usa Llc

Fluocinonide Cream 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Rebel Distributors Corp

Fluocinonide | Rebel Distributors Corp

FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base), FLUOCINONIDE GEL USP, 0.05% and FLUOCINONIDE OINTMENT USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Fluocinonide | Taro Pharmaceuticals U.s.a., Inc.

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Fluocinonide | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Fluocinonide Cream 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Fluocinonide | Lake Erie Medical Dba Quality Care Products Llc

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Medvantx, Inc.

Fluocinonide | Medvantx, Inc.

The topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Golden State Medical Supply, Inc.

Fluocinonide | Golden State Medical Supply, Inc.

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% and Flucinonide Topical Solution USP should be applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
A-s Medication Solutions Llc

Fluocinonide | A-s Medication Solutions Llc

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
A-s Medication Solutions Llc

Fluocinonide | A-s Medication Solutions Llc

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
A-s Medication Solutions Llc

Fluocinonide | A-s Medication Solutions Llc

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Oceanside Pharmaceuticals

Fluocinonide | Tris Pharma Inc

Administer hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution by the oral route only. Measure hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.9)].
2.1 Adults 18 Years of Age and Older
5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.

No Recall
Perrigo New York Inc

Fluocinonide | Perrigo New York Inc

For topical use only. Fluocinonide Cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of Fluocinonide Cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of Fluocinonide Cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14)].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream USP, 0.1% once or twice daily to the affected areas as directed by a physician.

No Recall
Teva Pharmaceuticals Usa Inc

Fluocinonide | Teva Pharmaceuticals Usa Inc

The topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Actavis Mid Atlantic Llc

Fluocinonide | Epic Pharma, Llc

Motion Sickness
The initial dose of 25 to 50 mg of meclizine hydrochloride should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Motion Sickness
The initial dose of 25 to 50 mg of meclizine hydrochloride should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

No Recall
Physicians Total Care, Inc.

Fluocinonide | Physicians Total Care, Inc.

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Preferred Pharmaceuticals, Inc.

Fluocinonide | Preferred Pharmaceuticals, Inc.

Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Proficient Rx Lp

Fluocinonide | Proficient Rx Lp

FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base), FLUOCINONIDE GEL USP, 0.05% and FLUOCINONIDE OINTMENT USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Glenmark Generics Inc., Usa

Fluocinonide | Glenmark Generics Inc., Usa

For topical use only. Fluocinonide cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14)].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected areas as directed by a physician.

No Recall
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Fluocinonide | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

For topical use only. Fluocinonide cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14)].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected areas as directed by a physician.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Fluocinonide | Taro Pharmaceuticals U.s.a., Inc.

For topical use only. Fluocinonide cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14)].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected areas as directed by a physician.

No Recall
Preferred Pharmaceuticals, Inc.

Fluocinonide | Preferred Pharmaceuticals, Inc.

Fluocinonide cream 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Fluocinonide | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Fluocinonide Cream USP, 0.05% (Emollient Base) is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Medsource Pharmaceuticals

Fluocinonide | Medsource Pharmaceuticals

The topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall