Desonide Ointment, 0.05% .5 mg/g
Desonide Ointment, 0.05% · OINTMENT · Bryant Ranch Prepack
Desonide Ointment, 0.05% is a ointment containing desonide ointment, 0.05% at .5 mg/g, taken topical. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Desonide Ointment, 0.05%
- Generic Name
- Desonide Ointment, 0.05%
- NDC Code (Product)
72162-1272- Manufacturer
- Bryant Ranch Prepack
- Strength
- .5 mg/g
- Dosage Form
- OINTMENT
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA210998
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 03/20/2019
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
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 Ointment, 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 Ointment, 0.05% should be applied to the affected area as a thin film from 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.
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%. These adverse reactions 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. To report SUSPECTED ADVERSE REACTIONS , contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Desonide Ointment, 0.05% used for?
Desonide Ointment, 0.05% contains Desonide Ointment, 0.05%. It is a ointment taken topical. Consult your doctor for specific uses.
Is Desonide Ointment, 0.05% a controlled substance?
Desonide Ointment, 0.05% is not classified as a controlled substance by the DEA.
What is the generic name for Desonide Ointment, 0.05%?
The generic name for Desonide Ointment, 0.05% is Desonide Ointment, 0.05%. There are no other listed brand versions of Desonide Ointment, 0.05%.
What is the NDC code for Desonide Ointment, 0.05% .5 mg/g?
The NDC (National Drug Code) for Desonide Ointment, 0.05% .5 mg/g is 72162-1272, listed by Bryant Ranch Prepack.
Other Desonide Ointment, 0.05% Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)