Source: FDA, National Drug Code (US) Revision Year: 2018
CUTIVATE (fluticasone propionate) Lotion USP, 0.05% contains fluticasone propionate, USP [S-Fluoromethyl 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate], a synthetic fluorinated corticosteroid, for topical use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Chemically, fluticasone propionate, USP is C25H31F3O5S.
It has the following structural formula:
Fluticasone propionate, USP has a molecular weight of 500.6. It is a white to off-white powder and is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
Each gram of CUTIVATE Lotion USP contains 0.5 mg fluticasone propionate, USP in a white to off white lotion base of cetomacrogol 1000, cetostearyl alcohol, citric acid monohydrate, dimethicone 350, imidurea, isopropyl myristate, methylparaben, propylene glycol, propylparaben, purified water, and sodium citrate.
| Dosage Forms and Strengths |
|---|
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Lotion, 0.05%. Each gram of CUTIVATE Lotion USP contains 0.5 mg fluticasone propionate, USP in a white to off-white lotion base. CUTIVATE Lotion USP is supplied in 120 mL bottles. |
| How Supplied |
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CUTIVATE (fluticasone propionate) Lotion USP, 0.05% is white to off-white in color, and supplied as follows: 120 mL bottle NDC 10337-434-04 |
| Drug | Countries | |
|---|---|---|
| CUTIVATE | Cyprus, Ecuador, Estonia, Hong Kong, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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