Drugplain

Amcinonide 1 mg/g

amcinonide · OINTMENT · Ayurax, LLC

No Recall History
Plain English

Amcinonide ointment is a prescription corticosteroid applied directly to the skin to reduce inflammation and itching caused by various skin conditions. It comes as a 1 mg/g strength ointment for topical use.

Key Facts

Brand Name
Amcinonide
Generic Name
amcinonide
NDC Code (Product)
73308-407
Manufacturer
Ayurax, LLC
Strength
1 mg/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
ANDA076096
Drug Class
Corticosteroid [EPC]
Marketing Start
05/01/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

arthralgia12 reports
pain in extremity12 reports
death11 reports
pain9 reports
malaise8 reports
fatigue7 reports
insomnia7 reports
musculoskeletal stiffness7 reports
pyrexia7 reports
anxiety6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

DOSAGE 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

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

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.

Frequently Asked Questions

What is Amcinonide used for?

Amcinonide ointment is a prescription corticosteroid applied directly to the skin to reduce inflammation and itching caused by various skin conditions. It comes as a 1 mg/g strength ointment for topical use.

Is Amcinonide a controlled substance?

Amcinonide is not classified as a controlled substance by the DEA.

What is the generic name for Amcinonide?

The generic name for Amcinonide is amcinonide. There are no other listed brand versions of amcinonide.

What is the NDC code for Amcinonide 1 mg/g?

The NDC (National Drug Code) for Amcinonide 1 mg/g is 73308-407, listed by Ayurax, LLC.

Product NDC

73308-407

Package NDC

73308-407-60

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)