Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE PADAGIS ISRAEL PHARMACEUTICALS LTD 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. Structural Formula

Drug Facts

Composition & Profile

Strengths
0.025 % 15 g 80 g 454 g 0.1 % 0.5 %
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 BOX
UNII
F446C597KA
Packaging

HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.025% is available as follows: 15 g tube (NDC 45802- 063 -35) 80 g tube (NDC 45802- 063 -36) 454 g jar (NDC 45802- 063 -05) Triamcinolone Acetonide Cream USP, 0.1% is available as follows: 15 g tube (NDC 45802- 064 -35) 80 g tube (NDC 45802- 064 -36) 454 g jar (NDC 45802- 064 -05) Triamcinolone Acetonide Cream USP, 0.5% is available as follows: 15 g tube (NDC 45802- 065 -35); Principal Display Panel - 0.025% Carton NDC 45802-063-35 Rx Only Triamcinolone Acetonide Cream USP, 0.025% NET WT 15 g Triamcinolone Acetonide Cream USP, 0.025% carton; Principal Display Panel - 0.5% Carton 45802-065-35 Rx Only Triamcinolone Acetonide Cream USP, 0.5% NET WT 15 g Triamcinolone Acetonide Cream USP, 0.5% carton; Package/Label Display Panel - 0.1% Carton NDC 45802-064-35 Rx Only Triamcinolone Acetonide Cream USP, 0.1% NET WT 15 g Triamcinolone Acetonide Cream USP, 0.1% carton

Package Descriptions
  • HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.025% is available as follows: 15 g tube (NDC 45802- 063 -35) 80 g tube (NDC 45802- 063 -36) 454 g jar (NDC 45802- 063 -05) Triamcinolone Acetonide Cream USP, 0.1% is available as follows: 15 g tube (NDC 45802- 064 -35) 80 g tube (NDC 45802- 064 -36) 454 g jar (NDC 45802- 064 -05) Triamcinolone Acetonide Cream USP, 0.5% is available as follows: 15 g tube (NDC 45802- 065 -35)
  • Principal Display Panel - 0.025% Carton NDC 45802-063-35 Rx Only Triamcinolone Acetonide Cream USP, 0.025% NET WT 15 g Triamcinolone Acetonide Cream USP, 0.025% carton
  • Principal Display Panel - 0.5% Carton 45802-065-35 Rx Only Triamcinolone Acetonide Cream USP, 0.5% NET WT 15 g Triamcinolone Acetonide Cream USP, 0.5% carton
  • Package/Label Display Panel - 0.1% Carton NDC 45802-064-35 Rx Only Triamcinolone Acetonide Cream USP, 0.1% NET WT 15 g Triamcinolone Acetonide Cream USP, 0.1% carton

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. Structural Formula

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 Padagis ® Yeruham, Israel www.padagis.com Rev 12-24 2N700 RC PH3


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