Label: TRIAMCINOLONE ACETONIDE- triamcinolone acetonide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 52565-048-15 - Packager: Teligent Pharma, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 3, 2017
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- Official Label (Printer Friendly)
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DESCRIPTIONThe topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as 9-fluoro-11b ...
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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 USAGETopical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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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 ADMINISTRATIONApply a thin film of triamcinolone acetonide ointment 0.5%, as appropriate, to the affected area two to three times daily. OCCLUSIVE DRESSING TECHNIQUE - Occlusive dressings may be used for the ...
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HOW SUPPLIEDTriamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 g tube (NDC 52565-048-15)
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STORAGEStore at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Mfd. and Dist by: Teligent Pharma, Inc. Buena, NJ 08310 - Revised: 12/16
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Principal Display Panel - 0.5% CartonNDC 52565-048-15 - Triamcinolone Acetonide - Ointment USP, 0.5% Net Wt. 15 grams - Rx Only - For External Use Only - Not for Ophthalmic Use
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INGREDIENTS AND APPEARANCEProduct Information