Drug Catalog - Product Detail
Betamethasone Valerate Aerosol Foam 0.12% 100 GM UoU
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50742-0315-01 | INGENUS PHARMACEUTICALS | 100 | 0.12% | NA |
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Description
DESCRIPTION Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C 27 H 37 FO 6 , a molecular weight of 476.58. The following is the chemical structure: Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone valerate foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60.4%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Chemical Structure
How Supplied
HOW SUPPLIED Betamethasone Valerate Foam, 0.12% is supplied in 50 gram and 100 gram aluminum cans in carton 50 g (50742-315-50) aluminum can 100 g (50742-315-01) aluminum can Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Rev. 08/2018 26717 ingenus
Indications & Usage
INDICATIONS AND USAGE Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
Dosage and Administration
DOSAGE AND ADMINISTRATION Note: For proper dispensing of foam, can must be inverted. For application to the scalp invert can and dispense a small amount of Betamethasone Valerate Foam, 0.12% onto a saucer or other cool surface. Do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Betamethasone Valerate Foam, 0.12% should not be used with occlusive dressings unless directed by a physician.