Drugplain

Desonide .5 mg/g

Desonide · CREAM · Sun Pharmaceutical Industries, Inc.

3 Recalls on RecordCurrently in Shortage
Plain English

Desonide cream is a prescription corticosteroid applied to the skin to reduce inflammation and itching caused by conditions like eczema and dermatitis. This medication works by decreasing swelling and irritation on affected areas of skin.

Key Facts

Brand Name
Desonide
Generic Name
Desonide
NDC Code (Product)
51672-1280
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
.5 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA073548
Drug Class
Corticosteroid [EPC]
Marketing Start
06/30/1992

Recall History

3 Recalls on Record
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II03/02/2017

Fougera Pharmaceuticals Inc.

Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective1,161 reports
macular degeneration780 reports
off label use409 reports
pain383 reports
nausea370 reports
headache318 reports
rash313 reports
pruritus308 reports
erythema306 reports
pyrexia300 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Desonide cream, 0.05% is a low potency corticosteroid 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 cream, 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 cream, 0.05% should not be used with occlusive dressings.

Contraindications

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

Adverse Reactions

ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide cream, 0.05% was approximately 1%. The adverse reactions for desonide cream, 0.05% were pruritus, pain, folliculitis, rash, peripheral edema, pustular rash, sweating, erythema, irritation, and burning. Laboratory abnormalities were found in 3% of the patients. These were hyperglycemia (2%) and liver function abnormality (1%). 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.

Frequently Asked Questions

What is Desonide used for?

Desonide cream is a prescription corticosteroid applied to the skin to reduce inflammation and itching caused by conditions like eczema and dermatitis. This medication works by decreasing swelling and irritation on affected areas of skin.

Is Desonide a controlled substance?

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

What is the generic name for Desonide?

The generic name for Desonide is Desonide. There are 1 other brand versions of Desonide.

What is the NDC code for Desonide .5 mg/g?

The NDC (National Drug Code) for Desonide .5 mg/g is 51672-1280, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

51672-1280

Package NDC

51672-1280-1

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

Data from openFDA · Public domain (CC0 1.0)