Hydrocortisone Butyrate Recall
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FDA Labeling Changes
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Hydrocortisone butyrate cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
There is currently no drug history available for this drug.
Hydrocortisone Butyrate Cream USP, 0.1% contains the topical corticosteroid hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: pregn-4-ene-3,20-dione, 11,21 - dihydroxy-17-[(1-oxobutyl)oxy]-, (11β-); the molecular formula: C25H36O6; the molecular weight: 432.54; and the CAS registry number: 13609-67-1.
Its structural formula is:
Each gram of hydrocortisone butyrate cream USP, 0.1% contains 1.0 mg of hydrocortisone butyrate in a hydrophilic base consisting of cetostearyl alcohol, ceteth-20, mineral oil, white petrolatum, citric acid, sodium citrate, propylparaben and butylparaben (preservatives) and purified water.