Amcinonide AMCINONIDE INA PHARMACEUTICS INC. FDA Approved The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Amcinonide Cream contains 1 mg of the active steroid amcinonide in a white, smooth, homogeneous, opaque emulsion composed of benzyl alcohol (as preservative), emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water and sorbitol solution 70%. Chemically, amcinonide is: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis (oxy)]-9-fluoro-11-hydroxy-, (11β, 16α). Chemical Structure
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Substance Amcinonide
Route
TOPICAL
Applications
ANDA076229
Package NDC

Drug Facts

Composition & Profile

Strengths
0.1 % 1 mg/g 60 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
UPC
0374157006605
UNII
423W026MA9
Packaging

HOW SUPPLIED Amcinonide Cream USP, 0.1% (1 mg/g) is supplied in: 60 g - NDC 74157-006-60 Store at 20° -25°C (68°-77°F) [see USP Controlled Room Temperature] DO NOT FREEZE.; Product label image description image description

Package Descriptions
  • HOW SUPPLIED Amcinonide Cream USP, 0.1% (1 mg/g) is supplied in: 60 g - NDC 74157-006-60 Store at 20° -25°C (68°-77°F) [see USP Controlled Room Temperature] DO NOT FREEZE.
  • Product label image description image description

Overview

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Amcinonide Cream contains 1 mg of the active steroid amcinonide in a white, smooth, homogeneous, opaque emulsion composed of benzyl alcohol (as preservative), emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water and sorbitol solution 70%. Chemically, amcinonide is: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis (oxy)]-9-fluoro-11-hydroxy-, (11β, 16α). Chemical Structure

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 three times daily depending on the severity of the condition. Occlusive dressings may be a valuable therapeutic adjunct 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 Miliaria

Storage & Handling

Store at 20° -25°C (68°-77°F) [see USP Controlled Room Temperature] DO NOT FREEZE.


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