Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE BRYANT RANCH PREPACK FDA Approved The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11ß,16α)-. C 24 H 31 FO 6 , and M.W. of 434.51; CAS Reg. No. 76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate.
FunFoxMeds box
Route
TOPICAL
Applications
ANDA086413
Package NDC

Drug Facts

Composition & Profile

Strengths
0.5 % 15 g
Treats Conditions
Indications And Usage Topical Corticosteroids Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
F446C597KA
Packaging

HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.5% is available as follows: 15 g tube (NDC 63629-8707-1) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504; Triamcinolone Acetonide 0.5% Cream, #15 Label

Package Descriptions
  • HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.5% is available as follows: 15 g tube (NDC 63629-8707-1) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
  • Triamcinolone Acetonide 0.5% Cream, #15 Label

Overview

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11ß,16α)-. C 24 H 31 FO 6 , and M.W. of 434.51; CAS Reg. No. 76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate.

Indications & Usage

Topical corticosteroids are 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 four 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

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. 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

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Perrigo Bronx, NY 10457 Distributed By Perrigo Allegan, MI 49010 • www.perrigo.com Rev 08-15 : 4B400 RC JX1


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