Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Betamethasone Dipropionate Cream USP, 0.05% is supplied as follows: 15 g tubes NDC 59651-891-14 45 g tubes NDC 59651-891-46 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and freezing. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: September 2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 15 g Tube Label NDC 59651-891-14 Rx only Betamethasone Dipropionate Cream, USP 0.05% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT 15 grams fig; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label NDC 59651-891-14 Rx only Betamethasone Dipropionate Cream, USP 0.05% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT 15 grams fig
- HOW SUPPLIED: Betamethasone Dipropionate Cream USP, 0.05% is supplied as follows: 15 g tubes NDC 59651-891-14 45 g tubes NDC 59651-891-46 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and freezing. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: September 2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 15 g Tube Label NDC 59651-891-14 Rx only Betamethasone Dipropionate Cream, USP 0.05% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT 15 grams fig
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label NDC 59651-891-14 Rx only Betamethasone Dipropionate Cream, USP 0.05% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT 15 grams fig
Overview
Betamethasone dipropionate cream, USP contains betamethasone dipropionate, 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 dipropionate USP is a white to cream white powder freely soluble in acetone and in chloroform; sparingly soluble in alcohol; insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is: Each gram of the 0.05% cream contains 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a soft, white to off-white, hydrophilic cream of cetostearyl alcohol, mineral oil, monobasic sodium phosphate (monohydrate), polyoxyl 20 cetostearyl ether, purified water, stearyl alcohol, white petrolatum; chlorocresol is present as a preservative. str
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 dipropionate cream to the affected skin areas once daily. In some cases, twice daily dosage may be necessary. If an infection develops, appropriate antimicrobial therapy should be instituted. Betamethasone dipropionate products should not be used with occlusive dressings.
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 when betamethasone dipropionate products are used as recommended in the DOSAGE AND ADMINISTRATION section. 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 infections, skin atrophy, striae and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.
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