Desonide

Desonide is an FDA drug label for the active ingredient DESONIDE manufactured by NORTHSTAR RX LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230914.

Generic: DESONIDE

Manufacturer: NORTHSTAR RX LLC

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 72603-164

Application: ANDA074254

Effective: 20230914

Indications & Usage

INDICATIONS AND USAGE Desonide ointment, 0.05% is a low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.

Dosage & Administration

DOSAGE AND ADMINISTRATION Desonide ointment, 0.05% should be applied to the affected area as a thin film two to four times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Desonide ointment, 0.05% should not be used with occlusive dressings.

Contraindications

CONTRAINDICATIONS Desonide ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

Not available.

Adverse Reactions

ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide ointment, 0.05% was approximately 6%. The adverse reactions for desonide ointment, 0.05% were erythema, induration, pruritus, irritation, oiliness, and peripheral edema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation.