Label: FLUOCINONIDE cream
FLUOCINONIDE gel
FLUOCINONIDE ointment
- NDC Code(s): 51672-1253-1, 51672-1253-2, 51672-1253-3, 51672-1253-4, view more
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 22, 2024
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONFor External Use Only. Not For Ophthalmic Use. Rx only
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DESCRIPTIONFluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active ...
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CLINICAL PHARMACOLOGYTopical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various ...
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INDICATIONS AND USAGEFluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory ...
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CONTRAINDICATIONSTopical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
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PRECAUTIONSGeneral - Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and ...
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ADVERSE REACTIONSThe following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an ...
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OVERDOSAGETopically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see - PRECAUTIONS).
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DOSAGE AND ADMINISTRATIONFluocinonide 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 ...
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HOW SUPPLIEDFluocinonide Cream USP, 0.05% is supplied in 15 g (NDC 51672-1253-1), 30 g (NDC 51672-1253-2), 60 g (NDC 51672-1253-3) and 120 g (NDC 51672-1253-4) tubes. Store at 20°-25°C (68°-77°F)[see USP ...
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SPL UNCLASSIFIED SECTIONMfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 - Dist. by: Taro Pharmaceuticals U.S.A., Inc.Hawthorne, NY 10532 - Revised: November, 2017 - PK-4964-5 ...
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PRINCIPAL DISPLAY PANEL - 30 g Tube Carton (Cream)NDC 51672-1253-2 - Fluocinonide - Cream USP, 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 30 g - Rx ...
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PRINCIPAL DISPLAY PANEL - 15 g Tube CartonNDC 51672-1254-1 - Fluocinonide - Cream USP, 0.05% (Emulsified Base) FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of ...
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PRINCIPAL DISPLAY PANEL - 15 g Tube CartonNDC 51672-1279-1 - Fluocinonide - Gel USP, 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 15 g - Rx ...
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PRINCIPAL DISPLAY PANEL - 15 g Tube CartonNDC 51672-1264-1 - Fluocinonide - Ointment USP, 0.05%
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INGREDIENTS AND APPEARANCEProduct Information