BETAMETHASONE DIPROPIONATE cream BETAMETHASONE DIPROPIONATE ointment BETAMETHASONE DIPROPIONATE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

betamethasone dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

betamethasone dipropionate

Composition:

betamethasone 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%
BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%
BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION:
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.
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive
actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroid