HALCINONIDE HALCINONIDE SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula: Each gram of 0.1% halcinonide cream, USP, contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide. Structure
FunFoxMeds box
Substance Halcinonide
Route
TOPICAL
Applications
NDA017556
Package NDC

Drug Facts

Composition & Profile

Strengths
0.1 % 60 g
Treats Conditions
Indications And Usage Halcinonide Cream Usp 0 1 Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0357664698365
UNII
SI86V6QNEG
Packaging

HOW SUPPLIED Halcinonide cream, USP, 0.1 % is smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is supplied as: NOC 57664-698-36 Tube containing 60 g; Halcinonide 60g Carton Label carton

Package Descriptions
  • HOW SUPPLIED Halcinonide cream, USP, 0.1 % is smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is supplied as: NOC 57664-698-36 Tube containing 60 g
  • Halcinonide 60g Carton Label carton

Overview

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula: Each gram of 0.1% halcinonide cream, USP, contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide. Structure

Indications & Usage

Halcinonide cream, USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Apply the 0.1% halcinonide cream, USP, to the affected area two to three times daily. Rub in gently. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply halcinonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. 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 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 (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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