Amcinonide Ointment
Name: Amcinonide Ointment
Amcinonide Ointment USP, 0.1%
Rx only
NOT FOR OPHTHALMIC USE.
FOR DERMATOLOGIC USE ONLY.
Description
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Each gram of Amcinonide Ointment USP, 0.1% contains 1 mg of the active steroid amcinonide in a specially formulated base composed of Benzyl Alcohol 2%, (wt/wt) as preservative, White Petrolatum, USP, Emulsifying Wax, and Antioxidant Blend (Propylene Glycol, Butylated Hydroxyanisole, Propyl Gallate and Citric Acid). Chemically, amcinonide is:
Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-16,17-[cyclopentylidenebis(oxy)]-9-fluoro-11-hydroxy-, (11β, 16α).
Indications and usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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.
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON
NDC 0168-0279-60
Rx only
FOUGERA®
AMCINONIDE
OINTMENT USP, 0.1%
NOT FOR OPHTHALMIC USE.
FOR DERMATOLOGIC USE ONLY.
NET WT 60 grams
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Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424) |