Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Betamethasone Dipropionate Betamethasone Dipropionate Betamethasone Dipropionate Cream USP, 0.05% Ointment USP, 0.05% Lotion USP, 0.05% is supplied as follows: is supplied as follows: is supplied as follows: 15 g tubes NDC 0168-0055-15 15 g tubes NDC 0168-0056-15 60 mL bottles NDC 0168-0057-60 45 g tubes NDC 0168-0055-46 45 g tubes NDC 0168-0056-46 Shake well before using. Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. E. FOUGERA & CO. A division of fougera PHARMACETICALS INC. Melville, New York 11747 46291737A R06/2021 #74; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45g CREAM CONTAINER NDC 0168-0055-46 FOUGERA ® BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 45 grams tube45g; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45g CREAM CARTON NDC 0168-0055-46 FOUGERA ® BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 45 grams carton45g; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15g OINTMENT CONTAINER NDC 0168-0056-15 FOUGERA ® BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 15 grams BDtube15gram; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15g OINTMENT CARTON NDC 0168-0056-15 FOUGERA ® BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 15 grams BDcarton15gram; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL LOTION CONTAINER NDC 0168-0057-60 FOUGERA ® BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone) 60 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60mL CONTAINER; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL LOTION CARTON NDC 0168-0057-60 FOUGERA ® BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone) 60 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60mL CTN
- HOW SUPPLIED: Betamethasone Dipropionate Betamethasone Dipropionate Betamethasone Dipropionate Cream USP, 0.05% Ointment USP, 0.05% Lotion USP, 0.05% is supplied as follows: is supplied as follows: is supplied as follows: 15 g tubes NDC 0168-0055-15 15 g tubes NDC 0168-0056-15 60 mL bottles NDC 0168-0057-60 45 g tubes NDC 0168-0055-46 45 g tubes NDC 0168-0056-46 Shake well before using. Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. E. FOUGERA & CO. A division of fougera PHARMACETICALS INC. Melville, New York 11747 46291737A R06/2021 #74
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45g CREAM CONTAINER NDC 0168-0055-46 FOUGERA ® BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 45 grams tube45g
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45g CREAM CARTON NDC 0168-0055-46 FOUGERA ® BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 45 grams carton45g
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15g OINTMENT CONTAINER NDC 0168-0056-15 FOUGERA ® BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 15 grams BDtube15gram
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15g OINTMENT CARTON NDC 0168-0056-15 FOUGERA ® BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 15 grams BDcarton15gram
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL LOTION CONTAINER NDC 0168-0057-60 FOUGERA ® BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone) 60 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60mL CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL LOTION CARTON NDC 0168-0057-60 FOUGERA ® BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone) 60 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60mL CTN
Overview
Betamethasone Dipropionate Cream, Ointment and Lotion contain 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% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate (monohydrate); chlorocresol is present as a preservative. Sodium hydroxide or phosphoric acid solution to adjust pH, if required. 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. Each gram of the 0.05% Lotion contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Sodium hydroxide solution to adjust pH, if required. 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 Dipropionate Cream or Ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary. Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears. Apply twice daily, in the morning and at night. 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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