Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Amcinonide Cream USP, 0.1% (1 mg/g) is supplied as follows: NDC 0168-0278-15 15 gram tubes NDC 0168-0278-30 30 gram tubes NDC 0168-0278-60 60 gram tubes Store at 20°C to 25°C (68°F to 77°F),excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. DO NOT FREEZE. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46260501A R03/2020 #53; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 GRAM TUBE NDC 0168-0278-15 Fougera ® AMCINONIDE CREAM USP, 0.1% Rx Only NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. NET WT 15 grams 15gramtube; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 GRAM CARTON NDC 0168-0278-15 Rx Only Fougera ® AMCINONIDE CREAM USP, 0.1% NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. WARNING: Keep out of reach of children. NET WT 15 grams 15gramcarton
- HOW SUPPLIED Amcinonide Cream USP, 0.1% (1 mg/g) is supplied as follows: NDC 0168-0278-15 15 gram tubes NDC 0168-0278-30 30 gram tubes NDC 0168-0278-60 60 gram tubes Store at 20°C to 25°C (68°F to 77°F),excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. DO NOT FREEZE. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46260501A R03/2020 #53
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 GRAM TUBE NDC 0168-0278-15 Fougera ® AMCINONIDE CREAM USP, 0.1% Rx Only NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. NET WT 15 grams 15gramtube
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 GRAM CARTON NDC 0168-0278-15 Rx Only Fougera ® AMCINONIDE CREAM USP, 0.1% NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. WARNING: Keep out of reach of children. NET WT 15 grams 15gramcarton
Overview
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Amcinonide Cream USP, 0.1% contains: 1 mg of active steroid Amcinonide, Benzyl Alcohol 2% (wt/wt) as preservative, Emulsifying Wax, Glycerin, Isopropyl Palmitate, Lactic Acid, Purified Water and Sorbitol Solution. Chemically, amcinonide is: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis(oxy)]-9-fluoro-11-hydroxy-, (11β, 16α). structure.jpg
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 and miliaria.
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