HALOG HALCINONIDE TOPICAL GENUS LIFESCIENCES 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 is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3, 20-dione cyclic 16, 17-acetal with acetone. Structural formula: C 24 H 32 ClFO 5 , MW 454.96, CAS-3093-35-4 Each mL of 0.1% HALOG SOLUTION (Halcinonide Topical Solution, USP) contains 1 mg halcinonide, edetate disodium, polyethylene glycol 300, and purified water with butylated hydroxytoluene as an antioxidant. Structure
FunFoxMeds bottle
Substance Halcinonide
Route
TOPICAL
Applications
NDA017823
Package NDC

Drug Facts

Composition & Profile

Strengths
0.1 % 120 ml
Quantities
120 ml
Treats Conditions
Indications And Usage Halog Solution Halcinonide Topical Solution Usp 0 1 Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
SI86V6QNEG
Packaging

HOW SUPPLIED HALOG® SOLUTION (Halcinonide Topical Solution, USP) 0.1% is supplied in plastic squeeze bottles containing 120 mL (NDC 64950-127-12) of solution. Storage Store at room temperature; avoid freezing and temperatures above 104° F. To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Genus Lifesciences Inc. Allentown, PA 18102 Revised: May 2025 5261181 50; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64950-127-12 HALOG ® SOLUTION (Halcinonide Topical Solution, USP 0.1%) FOR DERMATOLOGIC USE Not For Ophthalmic Use Net Wt. 120 ml Rx only carton label

Package Descriptions
  • HOW SUPPLIED HALOG® SOLUTION (Halcinonide Topical Solution, USP) 0.1% is supplied in plastic squeeze bottles containing 120 mL (NDC 64950-127-12) of solution. Storage Store at room temperature; avoid freezing and temperatures above 104° F. To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Genus Lifesciences Inc. Allentown, PA 18102 Revised: May 2025 5261181 50
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64950-127-12 HALOG ® SOLUTION (Halcinonide Topical Solution, USP 0.1%) FOR DERMATOLOGIC USE Not For Ophthalmic Use Net Wt. 120 ml Rx only carton label

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 is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3, 20-dione cyclic 16, 17-acetal with acetone. Structural formula: C 24 H 32 ClFO 5 , MW 454.96, CAS-3093-35-4 Each mL of 0.1% HALOG SOLUTION (Halcinonide Topical Solution, USP) contains 1 mg halcinonide, edetate disodium, polyethylene glycol 300, and purified water with butylated hydroxytoluene as an antioxidant. Structure

Indications & Usage

HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Apply HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1% to the affected area two to three times daily. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply the solution to 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 Topical Solution, USP 0.1% 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 solution 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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