Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE USP 0.05% ENCUBE ETHICALS, INC. 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 is designated chemically as 9-Fluoro-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Graphic Formula: C 24 H 31 FO 6 , MW 434.50 Each gram of 0.05% Triamcinolone Acetonide Ointment USP provides 0.5 mg of Triamcinolone Acetonide in a water­ in-oil emulsion composed of light mineral oil, purified water, white petrolatum, mineral oil, ceresin wax 155/165, and lanolin alcohols. triam-aceto.jpg
FunFoxMeds bottle
Route
TOPICAL
Applications
ANDA212384
Package NDC

Drug Facts

Composition & Profile

Strengths
430 g
Treats Conditions
Indications And Usage Triamcinolone Acetonide Ointment 0 05 Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0321922024111
UNII
F446C597KA
Packaging

HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.05%: jar containing 430 g ( NDC 21922-024-11) KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. You may report Side effects to FDA at 1-800-FDA-1088. You may also report side effects to Encube Ethicals Private Limited at (1-833-285-4151). DISPENSE IN A WELL-CLOSED CONTAINER CAUTION : Federal law prohibits dispensing without prescription. For external use only. Not for ophthalmic use. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa-403404, India. Distributed by: Encube Ethicals Inc. 200 Meredith Avenue, Suite101A Durham, NC 27713 USA. Revised : 04/2021; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 430 g Jar NDC 21922-024-11 Triamcinolone Acetonide Ointment USP, 0.05% Rx Only 430 g container-label-430g

Package Descriptions
  • HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.05%: jar containing 430 g ( NDC 21922-024-11) KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. You may report Side effects to FDA at 1-800-FDA-1088. You may also report side effects to Encube Ethicals Private Limited at (1-833-285-4151). DISPENSE IN A WELL-CLOSED CONTAINER CAUTION : Federal law prohibits dispensing without prescription. For external use only. Not for ophthalmic use. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa-403404, India. Distributed by: Encube Ethicals Inc. 200 Meredith Avenue, Suite101A Durham, NC 27713 USA. Revised : 04/2021
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 430 g Jar NDC 21922-024-11 Triamcinolone Acetonide Ointment USP, 0.05% Rx Only 430 g container-label-430g

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 is designated chemically as 9-Fluoro-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Graphic Formula: C 24 H 31 FO 6 , MW 434.50 Each gram of 0.05% Triamcinolone Acetonide Ointment USP provides 0.5 mg of Triamcinolone Acetonide in a water­ in-oil emulsion composed of light mineral oil, purified water, white petrolatum, mineral oil, ceresin wax 155/165, and lanolin alcohols. triam-aceto.jpg

Indications & Usage

Triamcinolone Acetonide Ointment 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Dosage & Administration

Apply a thin film of Triamcinolone Acetonide Ointment 0.05% to the affected area two to four 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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