Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE GLENMARK PHARMACEUTICALS INC., USA FDA Approved The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11, 16, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Structural Formula: C 24 H 31 FO 6 , MW 434.50 Each gram of 0.1% and 0.5% Triamcinolone Acetonide Ointment USP contains 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum. Triamcinolone Acetonide Structure

Drug Facts

Composition & Profile

Strengths
0.1 % 15 g 80 g 454 g 0.5 %
Quantities
17 count
Treats Conditions
Indications And Usage Triamcinolone Acetonide Ointment 0 1 And 0 5 Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOX
UPC
0368462797594 0368462798171 0368462797495
UNII
F446C597KA
Packaging

HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 g tube NDC 68462-797-17 80 g tube NDC 68462-797-49 454 g jar NDC 68462-797-59 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 g tube NDC 68462-798-17 Storage Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature] Manufactured by: Glenmark Pharmaceuticals Limited Village Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa December 2016; PACKAGE LABEL DISPLAY PANEL Triamcinolone_0.1%_80g_Tube; PACKAGE LABEL DISPLAY PANEL Triamcinolone_0.1%_80g_Carton; PACKAGE LABEL DISPLAY PANEL Triamcinolone_0.1%_454g_Jar; PACKAGE LABEL DISPLAY PANEL tube-1; PACKAGE LABEL DISPLAY PANEL carton-1

Package Descriptions
  • HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 g tube NDC 68462-797-17 80 g tube NDC 68462-797-49 454 g jar NDC 68462-797-59 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 g tube NDC 68462-798-17 Storage Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature] Manufactured by: Glenmark Pharmaceuticals Limited Village Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa December 2016
  • PACKAGE LABEL DISPLAY PANEL Triamcinolone_0.1%_80g_Tube
  • PACKAGE LABEL DISPLAY PANEL Triamcinolone_0.1%_80g_Carton
  • PACKAGE LABEL DISPLAY PANEL Triamcinolone_0.1%_454g_Jar
  • PACKAGE LABEL DISPLAY PANEL tube-1
  • PACKAGE LABEL DISPLAY PANEL carton-1

Overview

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11, 16, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Structural Formula: C 24 H 31 FO 6 , MW 434.50 Each gram of 0.1% and 0.5% Triamcinolone Acetonide Ointment USP contains 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum. Triamcinolone Acetonide Structure

Indications & Usage

Triamcinolone Acetonide Ointment 0.1% and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Apply a thin film of Triamcinolone Acetonide Ointment USP, 0.1% or 0.5%, 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 preparations.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (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.


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