Betamethasone Valerate

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Apply a thin film of Betamethasone Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Betamethasone Valerate Cream and Ointment contain betamethasone valerate USP, a synthetic adrenocorticosteroid 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% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, sodium phosphate monobasic (monohydrate), white petrolatum, polyethylene glycol 1000, ceteareth-15, stearyl alcohol, cetyl alcohol, propylene glycol, phosphoric acid (to adjust pH, if required); chlorocresol is present as a preservative.

Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum, mineral oil, and hydrogenated lanolin.

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Product: 50090-3794

NDC: 50090-3794-1 45 g in a TUBE / 1 in a CARTON