Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Betamethasone Valerate Ointment USP, 0.1% is supplied as follows: 15 g tubes NDC 71205-364-15 Store at room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Manufactured for: Cosette Pharmaceuticals, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 8-BETVGW1 Issued: 09/2015; PRINCIPAL DISPLAY PANEL 71205-364-15
- HOW SUPPLIED Betamethasone Valerate Ointment USP, 0.1% is supplied as follows: 15 g tubes NDC 71205-364-15 Store at room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Manufactured for: Cosette Pharmaceuticals, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 8-BETVGW1 Issued: 09/2015
- PRINCIPAL DISPLAY PANEL 71205-364-15
Overview
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
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 or Ointment 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. To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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