displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-. The structural formula is:
Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1 mg triamcinolone acetonide, in an ointment base of fractionated coconut oil and white petrolatum, with methylparaben and propylparaben as preservatives.
|Molecular Weight: 434.51
||Molecular Formula: C24H31FO6
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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 approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply a thin film of the 0.1% Triamcinolone Acetonide Ointment, as appropriate, to the affected area two to three times daily.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Triamcinolone Acetonide Ointment USP, 0.1% is supplied in 15 g (NDC 51672-1284-1), 30 g (NDC 51672-1284-2), and 80 g (NDC 51672-1284-8) tubes.
PRINCIPAL DISPLAY PANEL – 30 g Tube Carton
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Ointment USP, 0.1%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.