Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 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; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER NDC 0168-0040-15 Fougera ® BETAMETHASONE VALERATE CREAM USP, 0.1% (Potency expressed as betamethasone) Rx only NET WT 15 grams 15gtube; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CARTON NDC 0168-0040-15 Rx only Fougera ® BETAMETHASONE VALERATE CREAM USP, 0.1% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: Keep out of reach of children. NET WT 15 grams 15gcarton; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CONTAINER NDC 0168-0041-60 Fougera ® BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone) 60 mL FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 ML CONTAINER; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CARTON NDC 0168-0041-60 Fougera ® BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone) 60 mL FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx only PRINCIPAL DISPLAY PANEL - 60 ML CARTON; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER NDC 0168-0033-15 Fougera ® BETAMETHASONE VALERATE OINTMENT USP, 0.1% (Potency expressed as betamethasone) Rx only NET WT 15 grams PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 15 GRAM CONTAINER; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CARTON NDC 0168-0033-15 Rx only Fougera ® BETAMETHASONE VALERATE OINTMENT USP, 0.1% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: Keep out of reach of children. NET WT 15 grams PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 GRAM PANEL
- HOW SUPPLIED: 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
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER NDC 0168-0040-15 Fougera ® BETAMETHASONE VALERATE CREAM USP, 0.1% (Potency expressed as betamethasone) Rx only NET WT 15 grams 15gtube
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CARTON NDC 0168-0040-15 Rx only Fougera ® BETAMETHASONE VALERATE CREAM USP, 0.1% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: Keep out of reach of children. NET WT 15 grams 15gcarton
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CONTAINER NDC 0168-0041-60 Fougera ® BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone) 60 mL FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 ML CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CARTON NDC 0168-0041-60 Fougera ® BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone) 60 mL FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx only PRINCIPAL DISPLAY PANEL - 60 ML CARTON
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER NDC 0168-0033-15 Fougera ® BETAMETHASONE VALERATE OINTMENT USP, 0.1% (Potency expressed as betamethasone) Rx only NET WT 15 grams PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 15 GRAM CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CARTON NDC 0168-0033-15 Rx only Fougera ® BETAMETHASONE VALERATE OINTMENT USP, 0.1% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: Keep out of reach of children. NET WT 15 grams PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 GRAM PANEL
Overview
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. 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 Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective. Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.
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 with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. 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 infection, skin atrophy, striae and miliaria.
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