Drugplain

Topicort 2.5 mg/mL

Desoximetasone · SPRAY · Sun Pharmaceutical Industries, Inc.

2 Recalls on Record
Plain English

Topicort is a prescription corticosteroid spray applied to the skin to reduce inflammation and itching caused by various skin conditions. It comes as a 2.5 mg/mL spray for topical use.

Key Facts

Brand Name
Topicort
Generic Name
Desoximetasone
NDC Code (Product)
51672-5281
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
2.5 mg/mL
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
NDA204141
Drug Class
Corticosteroid [EPC]
Marketing Start
04/11/2013

Recall History

2 Recalls on Record
Class III08/05/2015

Taro Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

TerminatedVoluntary: Firm initiated
Class III03/31/2016

Taro Pharmaceuticals U.S.A., Inc.

Subpotent Drug

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective9,884 reports
pain8,925 reports
fatigue8,783 reports
alopecia8,233 reports
rheumatoid arthritis8,189 reports
systemic lupus erythematosus8,095 reports
pemphigus7,856 reports
abdominal discomfort7,798 reports
glossodynia7,631 reports
swelling7,132 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Topicort ® (desoximetasone ointment USP) 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply a thin film of Topicort ® (desoximetasone ointment USP) 0.05% to the affected skin areas twice daily. Rub in gently.

Warnings

WARNINGS Keep out of reach of children.

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. In controlled clinical studies the incidence of adverse reactions was low (0.2%) for Topicort ® (desoximetasone ointment USP) 0.05% and included mild burning sensation at the site of application.

Frequently Asked Questions

What is Topicort used for?

Topicort is a prescription corticosteroid spray applied to the skin to reduce inflammation and itching caused by various skin conditions. It comes as a 2.5 mg/mL spray for topical use.

Is Topicort a controlled substance?

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

What is the generic name for Topicort?

The generic name for Topicort is Desoximetasone. There are 10 other brand versions of Desoximetasone.

What is the NDC code for Topicort 2.5 mg/mL?

The NDC (National Drug Code) for Topicort 2.5 mg/mL is 51672-5281, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

51672-5281

Package NDC

51672-5281-0

Other Topicort Dosages

Other Desoximetasone Brands

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

Data from openFDA · Public domain (CC0 1.0)