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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  • SPL UNCLASSIFIED SECTION
    For External Use Only. Not For Ophthalmic Use. Rx only
  • DESCRIPTION
    Fluocinonide 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 ...
  • CLINICAL PHARMACOLOGY
    Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various ...
  • INDICATIONS AND USAGE
    Fluocinonide 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 ...
  • CONTRAINDICATIONS
    Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
  • PRECAUTIONS
    General - Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and ...
  • ADVERSE REACTIONS
    The 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 ...
  • OVERDOSAGE
    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see - PRECAUTIONS).
  • DOSAGE AND ADMINISTRATION
    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 ...
  • HOW SUPPLIED
    Fluocinonide 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 ...
  • SPL UNCLASSIFIED SECTION
    Mfd. 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 ...
  • 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 ...
  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
    NDC 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 ...
  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
    NDC 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 ...
  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
    NDC 51672-1264-1 - Fluocinonide - Ointment USP, 0.05%
  • INGREDIENTS AND APPEARANCE
    Product Information