Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Amcinonide Ointment USP, 0.1% (1 mg/g) is supplied as follows: NDC 73308-407-60; 60 gram tubes Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP). Manufactured for: Ayurax, LLC Fairhope, AL 36532 Rev. 09/23; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G TUBE NDC 73308-407-60 Ayurax LLC AMCINONIDE OINTMENT USP, 0.1% Rx only NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. NET WT 60 grams PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CONTAINER; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON: NDC 73308-407-60 Rx only Ayurax, LLC AMCINONIDE OINTMENT USP, 0.1% NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. NET WT 60 grams PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON
- HOW SUPPLIED: Amcinonide Ointment USP, 0.1% (1 mg/g) is supplied as follows: NDC 73308-407-60; 60 gram tubes Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP). Manufactured for: Ayurax, LLC Fairhope, AL 36532 Rev. 09/23
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G TUBE NDC 73308-407-60 Ayurax LLC AMCINONIDE OINTMENT USP, 0.1% Rx only NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. NET WT 60 grams PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON: NDC 73308-407-60 Rx only Ayurax, LLC AMCINONIDE OINTMENT USP, 0.1% NOT FOR OPHTHALMIC USE. FOR DERMATOLOGIC USE ONLY. NET WT 60 grams PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON
Overview
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). Chemical Formula
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. To report SUSPECTED ADVERSE REACTIONS, contact Pharm-Olam at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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