BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Approved Betamethasone dipropionate ointment 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 cream white odorless crystalline 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: Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. structure
FunFoxMeds box
Route
TOPICAL
Applications
ANDA215847

Drug Facts

Composition & Profile

Strengths
0.05 % 15 g 45 g
Quantities
14 count
Treats Conditions
Indications And Usage Topical Corticosteroids Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOX
UNII
826Y60901U
Packaging

HOW SUPPLIED: Betamethasone Dipropionate Ointment USP, 0.05% is supplied as follows: 15 g tubes NDC 45802-505-14 45 g tubes NDC 45802-505-84 Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Manufactured By Padagis ® Yeruham, Israel www.padagis.com Rev 03-24 65M00 RC PH2; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-505-14 Rx Only Betamethasone Dipropionate Ointment USP, 0.05% (Potency expressed as betamethasone) For Dermatologic Use Only. Not for Ophthalmic Use. NET WT 15 g Betamethasone Dipropionate Ointment USP, 0.05% carton

Package Descriptions
  • HOW SUPPLIED: Betamethasone Dipropionate Ointment USP, 0.05% is supplied as follows: 15 g tubes NDC 45802-505-14 45 g tubes NDC 45802-505-84 Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Manufactured By Padagis ® Yeruham, Israel www.padagis.com Rev 03-24 65M00 RC PH2
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-505-14 Rx Only Betamethasone Dipropionate Ointment USP, 0.05% (Potency expressed as betamethasone) For Dermatologic Use Only. Not for Ophthalmic Use. NET WT 15 g Betamethasone Dipropionate Ointment USP, 0.05% carton

Overview

Betamethasone dipropionate ointment 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 cream white odorless crystalline 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: Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. 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 ointment 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 ointment 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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