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FDA Labeling Changes
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Desonate Gel is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonate Gel for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate Gel to suppress the hypothalamic-pituitary-adrenal (HPA) axis (seePRECAUTIONS). Treatment should not exceed 4 consecutive weeks.
There is currently no drug history available for this drug.
Desonate Gel contains desonide (pregna-1,4-diene-3, 20-dione,11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-, (11ß,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C24H32O6. It has the following structural formula:
Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water.
Each gram of Desonate Gel contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium dihydrate, methylparaben, propylparaben, sodium hydroxide, and Carbopol® 981.