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Amcinonide
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Amcinonide | 1 mg/g | 197327 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Corticosteroid Hormone Receptor Agonists [MoA] | MoA | All 215 members |
| Corticosteroid [EPC] | EPC | All 215 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076065-001 | AMCINONIDE | CREAM | AMCINONIDE | Discontinued | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | May 15, 2003 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250707). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND 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.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
openFDA Drug LabelingADVERSE 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.
Description
openFDA Drug LabelingDESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Amcinonide Cream contains 1 mg of the active steroid amcinonide in a white, smooth, homogeneous, opaque emulsion composed of benzyl alcohol (as preservative), emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water and sorbitol solution 70%. Chemically, amcinonide is: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis (oxy)]-9-fluoro-11-hydroxy-, (11β, 16α). Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
How Supplied / Storage and Handling
openFDA Drug LabelingHOW 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
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: AMCINONIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 0168-0278-15 | 0168-0278 | Fougera Pharmaceuticals Inc. | 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBE | May 15, 2003 |
| 0168-0278-30 | 0168-0278 | Fougera Pharmaceuticals Inc. | 1 TUBE in 1 CARTON (0168-0278-30) / 30 g in 1 TUBE | May 15, 2003 |
| 0168-0278-60 | 0168-0278 | Fougera Pharmaceuticals Inc. | 1 TUBE in 1 CARTON (0168-0278-60) / 60 g in 1 TUBE | May 15, 2003 |
| 74157-006-60 | 74157-006 | INA PHARMACEUTICS INC. | 1 TUBE in 1 CARTON (74157-006-60) / 60 g in 1 TUBE | May 9, 2024 |
| 0168-0278 | 0168-0278 | Fougera Pharmaceuticals Inc. | — | May 15, 2003 |
| 74157-006 | 74157-006 | INA PHARMACEUTICS INC. | — | May 9, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.