Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Each gram contains betamethasone dipropionate 0.64 mg equivalent to betamethasone, USP 0.5 mg. Betamethasone Dipropionate Cream USP, 0.05% is white to off white cream, free from lumps and foreign matter with no phase separation is supplied as: NDC 16714-996-01 in tube of 15 g NDC 16714-996-02 in tube of 45 g Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to Northstar Rx LLC at Tel.: 1-800-206-7821.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Betamethasone dipropionate cream USP, 0.05% NDC 16714-996-01 15 g Rx only image image
- HOW SUPPLIED Each gram contains betamethasone dipropionate 0.64 mg equivalent to betamethasone, USP 0.5 mg. Betamethasone Dipropionate Cream USP, 0.05% is white to off white cream, free from lumps and foreign matter with no phase separation is supplied as: NDC 16714-996-01 in tube of 15 g NDC 16714-996-02 in tube of 45 g Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to Northstar Rx LLC at Tel.: 1-800-206-7821.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Betamethasone dipropionate cream USP, 0.05% NDC 16714-996-01 15 g Rx only image image
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, USP is a white to almost white crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol and freely soluble in acetone, methylene chloride and chloroform. 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 contains 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white cream of cetomacrogol 1000, cetostearyl alcohol, mineral oil, purified water, sodium phosphate monobasic, white petrolatum and chlorocresol is present as preservative. Image
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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