TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE DIRECT_RX FDA Approved The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: [Triamcinolone Acetonide Structure] Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.
FunFoxMeds box
Route
TOPICAL
Applications
ANDA088042 ANDA209535

Drug Facts

Composition & Profile

Strengths
0.1 % 15 g 30 g 80 g 454 g 0.025 % 0.5 %
Treats Conditions
Triamcinolone Acetonide Cream Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
UNII
F446C597KA
Packaging

Triamcinolone acetonide cream USP 0.1% is supplied in 15 g tube 30 g tube 80 g tube 454 g jar Triamcinolone acetonide cream USP 0.025% is supplied in 15 g tube 80 g tube 454 g jar Triamcinolone acetonide cream USP 0.5% is supplied in 15 g tube NDC 67877-318-15 Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 P1810.01 Revised: Sept 2015; 039-80; 277

Package Descriptions
  • Triamcinolone acetonide cream USP 0.1% is supplied in 15 g tube 30 g tube 80 g tube 454 g jar Triamcinolone acetonide cream USP 0.025% is supplied in 15 g tube 80 g tube 454 g jar Triamcinolone acetonide cream USP 0.5% is supplied in 15 g tube NDC 67877-318-15 Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 P1810.01 Revised: Sept 2015
  • 039-80
  • 277

Overview

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: [Triamcinolone Acetonide Structure] Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

Indications & Usage

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

Dosage & Administration

Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

Warnings & Precautions
No warnings available yet.
Contraindications

Triamcinolone acetonide cream is 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 Miliaria


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