DailyMed Label: Betamethasone Valerate

DailyMed Label: Betamethasone Valerate

2024

DailyMed Prescription

Betamethasone Valerate

Betamethasone Valerate

REMEDYREPACK INC.

NDC: 70518-3137

NDC: 70518-3137

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. structural formula

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.

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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.

Betamethasone Valerate Cream USP, 0.1% is supplied as follows: NDC: 70518-3137-00 PACKAGING: 1 in 1 CARTON, 15 g in 1 TUBE TYPE 0 Store at room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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.

DRUG: Betamethasone Valerate GENERIC: Betamethasone Valerate DOSAGE: CREAM ADMINSTRATION: TOPICAL NDC: 70518-3137-0 COLOR: white PACKAGING: 15 g in 1 TUBE OUTER PACKAGING: 1 in 1 CARTON ACTIVE INGREDIENT(S): BETAMETHASONE VALERATE 1.2mg in 1g INACTIVE INGREDIENT(S): WATER MINERAL OIL SODIUM PHOSPHATE, MONOBASIC PETROLATUM POLYETHYLENE GLYCOL 1000 CETEARETH-15 STEARYL ALCOHOL CETYL ALCOHOL PROPYLENE GLYCOL PHOSPHORIC ACID CHLOROCRESOL Remedy_Label