Label: DESONIDE cream

  • NDC Code(s): 62332-632-15, 62332-632-60
  • Packager: Alembic Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 22, 2023

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  • DESCRIPTION
    Desonide cream, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The ...
  • CLINICAL PHARMACOLOGY
    Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in ...
  • 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 ...
  • CONTRAINDICATIONS
    Desonide cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
  • PRECAUTIONS
    General - Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency ...
  • ADVERSE REACTIONS
    In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide cream, 0.05% was approximately 1%. These adverse reactions were pruritus, pain ...
  • OVERDOSAGE
    Topically applied desonide cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
  • 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 ...
  • HOW SUPPLIED
    Desonide cream, 0.05% is white to off white cream available as follows: 15 g tube (NDC 62332-632-15) 60 g tube (NDC 62332-632-60)
  • STORAGE
    Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Rx Only - NDC 62332-632-15 - Desonide Cream, 0.05% 15 grams - carton label
  • INGREDIENTS AND APPEARANCE
    Product Information