Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved 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: Molecular Weight: 434.51 Molecular Formula: C 24 H 31 FO 6 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. Chemical Structure
FunFoxMeds box
Route
TOPICAL
Applications
ANDA040037

Drug Facts

Composition & Profile

Strengths
0.1 % 15 g 30 g 80 g
Quantities
2 count
Treats Conditions
Indications And Usage Triamcinolone Acetonide Ointment Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOX
UNII
F446C597KA
Packaging

HOW SUPPLIED 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. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-1284-2 30 g Triamcinolone Acetonide Ointment USP, 0.1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO Principal Display Panel - 30 g Tube Carton

Package Descriptions
  • HOW SUPPLIED 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. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-1284-2 30 g Triamcinolone Acetonide Ointment USP, 0.1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO Principal Display Panel - 30 g Tube Carton

Overview

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: Molecular Weight: 434.51 Molecular Formula: C 24 H 31 FO 6 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. Chemical Structure

Indications & Usage

Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Apply a thin film of the 0.1% Triamcinolone Acetonide Ointment, as appropriate, to the affected area two to three times daily. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply Triamcinolone Acetonide Ointment under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Warnings & Precautions
No warnings available yet.
Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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 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.

Storage & Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


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