Clobetasol Propionate Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/wk because of the potential for the drug to suppress the HPA axis.
This product is not recommended for use in children under 12 years of age.
There is currently no drug history available for this drug.
Clobetasol propionate topical solution contains the active compound clobetasol propionate, 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.
Chemically, clobetasol propionate is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:
Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water.
Clobetasol propionate topical solution contains clobetasol propionate 0.05% (0.5 mg/g) in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide. It may also contain hydrochloric acid to adjust pH.
Clobetasol Propionate Solution Manufacturers
Rebel Distributors Corp
Physicians Total Care, Inc.
Hi-tech Pharmacal Co., Inc.
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Morton Grove Pharmaceuticals, Inc.
Taro Pharmaceuticals U.s.a., Inc.
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