Desonide .5 mg/g
Desonide · OINTMENT · Padagis Israel Pharmaceuticals Ltd
Desonide is a ointment containing desonide at .5 mg/g, taken topical. Manufactured by Padagis Israel Pharmaceuticals Ltd.
Key Facts
- Brand Name
- Desonide
- Generic Name
- Desonide
- NDC Code (Product)
45802-423- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Strength
- .5 mg/g
- Dosage Form
- OINTMENT
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA017426
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 08/22/2006
Recall History
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Fougera Pharmaceuticals Inc.
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
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.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 contains Desonide. It is a ointment taken topical. Consult your doctor for specific uses.
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 45802-423, listed by Padagis Israel Pharmaceuticals Ltd.