Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Halcinonide Topical Solution, USP 0.1% is supplied in plastic squeeze bottles containing 120 mL (NDC 74157-012-12) of solution. Storage Store at room temperature; avoid freezing and temperatures above 104° F. To report SUSPECTED ADVERSE REACTIONS, contact INA Pharmaceutics Inc at 1- 866-835-0469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: INA PHARMACEUTICS INC. FAIRMONT W V 26554; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 74157-012-12 Halcinonide Topical Solution, USP 0.1% FOR DERMATOLOGIC USE Not For Ophthalmic Use Net Wt. 120 ml Rx only image description image description
- HOW SUPPLIED Halcinonide Topical Solution, USP 0.1% is supplied in plastic squeeze bottles containing 120 mL (NDC 74157-012-12) of solution. Storage Store at room temperature; avoid freezing and temperatures above 104° F. To report SUSPECTED ADVERSE REACTIONS, contact INA Pharmaceutics Inc at 1- 866-835-0469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: INA PHARMACEUTICS INC. FAIRMONT W V 26554
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 74157-012-12 Halcinonide Topical Solution, USP 0.1% FOR DERMATOLOGIC USE Not For Ophthalmic Use Net Wt. 120 ml Rx only image description image description
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. Graphic formula: C 24 H 32 ClFO 5 , MW 454.96, CAS-3093-35-4 Each mL of 0.1% 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
Halcinonide Topical Solution, USP 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Apply 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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