Betamethasone Valerate Ointment Recall
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FDA Labeling Changes
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Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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Betamethasone Valerate Cream and Betamethasone Valerate Ointment contain Betamethasone Valerate USP (9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate); its empirical formula is C27H37FO6; its molecular weight is 476.59 (CAS Registry Number 2152-44-5); its structural formula is:
Each gram of the 0.1% cream contains 1.2 mg betamethasone valerate (equivalent to 1.0 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol, monobasic sodium phosphate, phosphoric acid or sodium hydroxide and 4-chloro-m-cresol as a preservative. Each gram of the 0.1% ointment contains 1.2 mg betamethasone valerate (equivalent to 1.0 mg betamethasone) in an ointment base consisting of mineral oil, white petrolatum and hydrogenated lanolin.