BETAMETHASONE VALERATE cream BETAMETHASONE VALERATE ointment BETAMETHASONE VALERATE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

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

INN (International Name):

BETAMETHASONE VALERATE

Composition:

BETAMETHASONE 1 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 Valerate Betamethasone Valerate Betamethasone Valerate Cream USP, 0.1% Ointment USP, 0.1% Lotion USP, 0.1% is supplied as follows: is supplied as follows: is supplied as follows: 15 g tubes NDC 0168-0040-15 15 g tubes NDC 0168-0033-15 60 mL bottles NDC 0168-0041-60 45 g tubes NDC 0168-0040-46 45 g tubes NDC 0168-0033-46 Shake well before using. Store away from heat and protect from light. Store at room temperature 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, NY 11747 46289058A R06/2021 #57

Authorization status:

New Drug Application

Summary of Product characteristics

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE OINTMENT
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE LOTION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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BETAMETHASONE VALERATE CREAM USP, 0.1%
BETAMETHASONE VALERATE OINTMENT USP, 0.1%
BETAMETHASONE VALERATE LOTION USP, 0.1%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Betamethasone Valerate Cream, Ointment and Lotion contain
betamethasone valerate
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 valerate is a white to practically white odorless
crystalline powder
practically insoluble in water, freely soluble in acetone and
chloroform, soluble in alcohol,
and slightly soluble in benzene and ether. Chemically, it is
9-fluoro-11β,17,21-trihydroxy-
16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural
formula is:
Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate
(equivalent to 1
mg betamethasone) in a soft, white, hydrophilic cream of purified
water, mineral oil,
white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol,
monobasic sodium
phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if
required);
chlorocresol is present as a preservative.
Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate
(equivalent to
1 mg betamethasone) in an ointment base of white petrolatum and
mineral oil.
Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate
(equivalent to 1
mg betamethasone) in a vehicle of isopropyl alcohol and water slightly
thickened with
carbomer 934P. Sodium hydroxide is used to adjust pH.
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids