Betamethasone Dipropionate (Page 2 of 2)

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin film of betamethasone dipropionate ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary.

If an infection develops, appropriate antimicrobial therapy should be instituted. Betamethasone dipropionate products should not be used with occlusive dressings.

HOW SUPPLIED

Each gram contains betamethasone dipropionate, USP 0.64 mg equivalent to betamethasone, 0.5 mg.

Betamethasone dipropionate ointment USP, 0.05% is supplied as:

NDC 72578-093-01 in tube of 15 g

NDC 72578-093-06 in tube of 45 g

Storage:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing.

Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

Manufactured by:

Zydus Lifesciences Ltd.

Changodar, Ahmedabad, India

Distributed by:

Viona Pharmaceuticals Inc.

Cranford, NJ 07016

Rev.: 09/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betamethasone dipropionate ointment USP, 0.05%

15 gm

NDC 72578-093-01

Rx only

BETAMETHASONE DIPROPIONATE betamethasone dipropionate ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-093 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength MINERAL OIL PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72578-093-01 1 TUBE in 1 CARTON contains a TUBE 1 15 g in 1 TUBE This package is contained within the CARTON (72578-093-01) 2 NDC:72578-093-06 1 TUBE in 1 CARTON contains a TUBE 2 45 g in 1 TUBE This package is contained within the CARTON (72578-093-06)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214048 07/20/2020

Labeler — Viona Pharmaceuticals Inc (081468959)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		650650802	ANALYSIS (72578-093), MANUFACTURE (72578-093)

Revised: 10/2022 Viona Pharmaceuticals Inc