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 VALERATE - UNII:9IFA5XM7R2)

Available from:

Physicians Total Care, Inc.

INN (International Name):

BETAMETHASONE VALERATE

Composition:

BETAMETHASONE VALERATE 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 cortico-steroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Store at controlled room temperature 15° - 30°C (59° - 86°F). E. FOUGERA & CO. A division of Nycomed US Inc. Melville, NY 11747 I240D R12/07 #57 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE VALERATE - BETAMETHASONE VALERATE CREAM
BETAMETHASONE VALERATE - BETAMETHASONE VALERATE OINTMENT
BETAMETHASONE VALERATE - BETAMETHASONE VALERATE LOTION
PHYSICIANS TOTAL CARE, 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
adrenocortico-steroid 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,
polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol,
monobasic sodium phosphate and
phosphoric acid or sodium hydroxide; 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.
Phosphoric acid or sodium hydroxide is used to adjust pH.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids is unclear. Various
laborator