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Clobetasol Propionate Emollient Formulation Recall
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Clobetasol Propionate Foam, 0.05% (Emulsion) is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.
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- Clobetasol Propionate Foam, 0.05% (Emulsion) should not be applied to the face, axillae, or groin.
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- Clobetasol Propionate Foam, 0.05% (Emulsion) should not be used if there is skin atrophy at the treatment site.
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- Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams or more than 21 capfuls per week.
History
There is currently no drug history available for this drug.
Other Information
Clobetasol Propionate Foam, 0.05% (Emulsion), a petrolatum-based emulsion aerosol foam, contains the active ingredient clobetasol propionate, USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
Clobetasol propionate is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97.
The following is the chemical structure:
Clobetasol propionate is a white to cream-colored crystalline powder, practically insoluble in water.
Each gram of Clobetasol Propionate Foam, 0.05% (Emulsion) contains 0.5 mg clobetasol propionate, USP. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, glycerin, isopropyl myristate, polyoxyl 20 cetostearyl ether, potassium citrate monohydrate, propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as a preservative.
Clobetasol Propionate Foam, 0.05% (Emulsion) is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.
Sources
Clobetasol Propionate Emollient Formulation Manufacturers
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Perrigo New York Inc
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