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

AMCINONIDE 
Amcinonide Ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0279
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMCINONIDE (AMCINONIDE) AMCINONIDE 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
BENZYL ALCOHOL  
BUTYLATED HYDROXYANISOLE  
PROPYL GALLATE  
CITRIC ACID MONOHYDRATE  
PROPYLENE GLYCOL  
Packaging
# Item Code Package Description
1 NDC:0168-0279-60 1 TUBE in 1 CARTON
1 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076096 04/03/2014
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
Revised: 04/2014   E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
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