TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE REMEDYREPACK INC. 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-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is: 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. Structure
FunFoxMeds box
Route
TOPICAL
Applications
ANDA088042
Product NDC
Package NDC

Drug Facts

Composition & Profile

Strengths
0.1 % 15 g
Quantities
00 pack 0 pack
Treats Conditions
Indications 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, 0.1% is supplied in: NDC: 70518-1524-00 PACKAGING: 15 g in 1 TUBE, TYPE 0 Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762; DRUG: TRIAMCINOLONE ACETONIDE GENERIC: TRIAMCINOLONE ACETONIDE DOSAGE: CREAM ADMINSTRATION: TOPICAL NDC: 70518-1524-0 PACKAGING: 15 g in 1 TUBE ACTIVE INGREDIENT(S): TRIAMCINOLONE ACETONIDE 1mg in 1g INACTIVE INGREDIENT(S): MINERAL OIL PROPYLENE GLYCOL SORBITOL CETYL PALMITATE SORBIC ACID POTASSIUM SORBATE WATER MM1

Package Descriptions
  • HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.1% is supplied in: NDC: 70518-1524-00 PACKAGING: 15 g in 1 TUBE, TYPE 0 Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
  • DRUG: TRIAMCINOLONE ACETONIDE GENERIC: TRIAMCINOLONE ACETONIDE DOSAGE: CREAM ADMINSTRATION: TOPICAL NDC: 70518-1524-0 PACKAGING: 15 g in 1 TUBE ACTIVE INGREDIENT(S): TRIAMCINOLONE ACETONIDE 1mg in 1g INACTIVE INGREDIENT(S): MINERAL OIL PROPYLENE GLYCOL SORBITOL CETYL PALMITATE SORBIC ACID POTASSIUM SORBATE WATER MM1

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-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is: 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. Structure

Indications & Usage

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

Dosage & Administration

DOSAGE & ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film two to four times daily for the 0.025% strength and two or three times daily for the 0.1% and 0.5% strength depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. 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 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, and miliaria.


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