Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Betamethasone Dipropionate Lotion, USP 0.05% is supplied as follows: 60 mL bottles (NDC 0713-0807-53) Shake well before using. 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 Iss. 03/2021 8-0807CPLNC1 VC7520; PRINCIPAL DISPLAY PANEL NDC 0713-0807-53 Betamethasone Dipropionate Lotion, USP 0.0.5% 60 mL Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. Text

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- HOW SUPPLIED: Betamethasone Dipropionate Lotion, USP 0.05% is supplied as follows: 60 mL bottles (NDC 0713-0807-53) Shake well before using. 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 Iss. 03/2021 8-0807CPLNC1 VC7520
- PRINCIPAL DISPLAY PANEL NDC 0713-0807-53 Betamethasone Dipropionate Lotion, USP 0.0.5% 60 mL Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. Text

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Overview
Betamethasone Dipropionate Lotion, 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 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: Molecular Formula: C 28 H 37 FO 7 Molecular Weight: 504.60 Each gram 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 974P. 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 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. 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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