DailyMed Label: Desonide

DailyMed Label: Desonide

2022

DailyMed Prescription

Desonide

Desonide

Unit Dose Services

NDC: 50436-3300

NDC: 50436-3300

NDC: 50436-3300

NDC: 50436-3300

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 corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Cream, 0.05% is C 24 H 32 O 6 . It has the following structural formula: The molecular weight of desonide is 416.51. It is a white to off-white powder. The solubility of desonide in distilled water saturated with ether is 184 mg/L. Each gram of Desonide Cream, contains 0.5 milligram of desonide microdispersed in a compatible vehicle buffered to the pH range of normal skin. It contains aluminum sulfate, calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral oil, purified water, sodium lauryl sulfate, synthetic white wax and white petrolatum. Preserved with methylparaben.

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.

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.

Desonide Cream, 0.5% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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, 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%).

Product: 50436-3300 NDC: 50436-3300-1 60 g in a TUBE / 1 in a CARTON

Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .