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Drug Catalog - Product Detail

BETAMETHASONE VALERATE LOTION LOT 0.001 60ML

NDC Mfr Size Str Form
54879-0004-60 STI PHARMA 60 0.1% LOTION
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Description
DESCRIPTION: Betamethasone Valerate Lotion contains betamethasone valerate USP, a synthetic adrenocortico-steroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural formula is: Each gram of the 0.1% Lotion contains 1.2 mg of betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Phosphoric acid or sodium hydroxide is used to adjust the pH. Betamethasone Structure
How Supplied
HOW SUPPLIED Betamethasone Valerate Lotion USP, 0.1% is supplied as follows: 60ml bottles NDC 54879-004-60 Shake well before using. Store at controlled room temperature 15° - 30°C (59° - 86°F). To report SUSPECTED ADVERSE REACTIONS, contact STI Pharma,LLC at 1-888-301-9680 or FDA at 1-800-FDA-1088 or ww.fda.gov/medwatch Manufactured for : STI Pharma LLC Newtown, PA 18940
Indications & Usage
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.