Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 68788-7451-01) and 45 gram (NDC 68788-7451-04) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - NDC 68788-7451 Betamethasone Valerate Cream USP, 0.1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO Relabeled by Preferred Pharmaceuticals, Inc. Betamethasone Valerate Cream USP 01%
- HOW SUPPLIED Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 68788-7451-01) and 45 gram (NDC 68788-7451-04) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - NDC 68788-7451 Betamethasone Valerate Cream USP, 0.1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO Relabeled by Preferred Pharmaceuticals, Inc. Betamethasone Valerate Cream USP 01%
Overview
Betamethasone Valerate Cream USP, 0.1% contains 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: Molecular Formula: C 27 H 37 FO 6 Molecular Weight: 476.59 Each gram of Betamethasone Valerate Cream USP, 0.1% contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of ceteareth-15, cetyl alcohol, mineral oil, polyethylene glycol 1000, propylene glycol, purified water, stearyl alcohol, white petrolatum, phosphoric acid and sodium hydroxide (for pH adjustment); chlorocresol is present as a preservative. Chemical Structure
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Apply a thin film of Betamethasone Valerate Cream USP, 0.1% to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.
Warnings & Precautions
No warnings available yet.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
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.
Storage & Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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