Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE REDPHARMDRUG FDA Approved The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic 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,16ą)-. C 24 H 31 FO 6 , M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP. image description
FunFoxMeds box
Route
TOPICAL
Applications
ANDA089796
Package NDC

Drug Facts

Composition & Profile

Strengths
0.025 % 15 g 80 g 0.1 % 30 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 Ointment USP, 0.025% is available as follows: 15 g tube (NDC 0713-0229-15) 80 g tube (NDC 0713-0229-80) Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 g tube (NDC 0713-0228-15) 30 g tube (NDC 0713-0228-31) 80 g tube (NDC 0713-0228-80); PRINICIPAL DISPLAY PANEL NDC 0713-0228-15 Triamcinolone Acetonide Ointment, USP 0.1% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0228-31 Triamcinolone Acetonide Ointment, USP 0.1% 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0228-80 Triamcinolone Acetonide Ointment, USP 0.1% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0229-15 Triamcinolone Acetonide Ointment, USP 0.025% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0229-80 Triamcinolone Acetonide Ointment, USP 0.025% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. image description image description image description image description image description

Package Descriptions
  • HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 g tube (NDC 0713-0229-15) 80 g tube (NDC 0713-0229-80) Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 g tube (NDC 0713-0228-15) 30 g tube (NDC 0713-0228-31) 80 g tube (NDC 0713-0228-80)
  • PRINICIPAL DISPLAY PANEL NDC 0713-0228-15 Triamcinolone Acetonide Ointment, USP 0.1% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0228-31 Triamcinolone Acetonide Ointment, USP 0.1% 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0228-80 Triamcinolone Acetonide Ointment, USP 0.1% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0229-15 Triamcinolone Acetonide Ointment, USP 0.025% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0229-80 Triamcinolone Acetonide Ointment, USP 0.025% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. image description image description image description image description image description

Overview

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic 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,16ą)-. C 24 H 31 FO 6 , M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP. image description

Indications & Usage

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Dosage & Administration

Apply Triamcinolone Acetonide Ointment USP 0.025% to the affected area two to four times daily. Rub in gently. Apply Triamcinolone Acetonide Ointment USP 0.1% to the affected area two to three times daily. Rub in gently. 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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Storage & Handling

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 07/2024 8-TRIAOICPLNC3 VC7777


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