Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Betamethasone Dipropionate Cream USP, 0.05% is supplied as follows: 15 g tube (NDC 0713-0659-15) 45 g tube (NDC 0713-0659-37) Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 06/2022 8-0659CPLNC2 VC7631; PRINCIPAL DISPLAY PANEL NDC 0713-0659-15 Betamethasone Dipropionate Cream, USP 0.05% 15 g Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0659-37 Betamethasone Dipropionate Cream, USP 0.05% 45 g Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPTHALMIC USE. Cosette Pharmaceuticals, Inc. betame1 betame3
- HOW SUPPLIED Betamethasone Dipropionate Cream USP, 0.05% is supplied as follows: 15 g tube (NDC 0713-0659-15) 45 g tube (NDC 0713-0659-37) Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 06/2022 8-0659CPLNC2 VC7631
- PRINCIPAL DISPLAY PANEL NDC 0713-0659-15 Betamethasone Dipropionate Cream, USP 0.05% 15 g Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0659-37 Betamethasone Dipropionate Cream, USP 0.05% 45 g Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPTHALMIC USE. Cosette Pharmaceuticals, Inc. betame1 betame3
Overview
Betamethasone Dipropionate Cream USP, 0.05% 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 is a white to almost white powder 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: Molecular Formula: C 28 H 37 FO 7 Molecular Weight: 504.60 Each gram of the 0.05% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a soft,white to off white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetyl alcohol, stearyl alcohol, monobasic sodium phosphate, chlorocresol is present as a preservative. Sodium hydroxide or phosphoric acid solution to adjust pH, if required. molecular-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 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 Cream 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. 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 .
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