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VUSION

These highlights do not include all the information needed to use VUSION Ointment safely and effectively. See full prescribing information for VUSION Ointment. VUSION® (miconazole nitrate, zinc oxide, and white petrolatum) Ointment, for topical use only Initial U.S. Approval: 2006

Approved
Approval ID

8d8aaac5-3203-4ade-ae74-e2ea469dae18

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 20, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

miconazole nitrate, zinc oxide, white petrolatum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6246
Application NumberNDA021026
Product Classification
M
Marketing Category
C73594
G
Generic Name
miconazole nitrate, zinc oxide, white petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 20, 2011
FDA Product Classification

INGREDIENTS (5)

MICONAZOLE NITRATEActive
Quantity: 2.5 mg in 1 g
Code: VW4H1CYW1K
Classification: ACTIB
PETROLATUMActive
Quantity: 813.5 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB
ZINC OXIDEActive
Quantity: 150 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCOL STEARATEInactive
Code: 0324G66D0E
Classification: IACT

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VUSION - FDA Drug Approval Details