gynazole 1
GYNAZOLE•1 Butoconazole Nitrate Vaginal Cream USP, 2% IN ONE PREFILLED DISPOSABLE APPLICATOR For Vaginal Use Only. Rx Only
Approved
Approval ID
125d8ede-db38-4eb9-a6be-19208687f36a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2023
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
butoconazole nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-396
Application NumberANDA200923
Product Classification
M
Marketing Category
C73584
G
Generic Name
butoconazole nitrate
Product Specifications
Route of AdministrationVAGINAL
Effective DateDecember 10, 2021
FDA Product Classification
INGREDIENTS (12)
BUTOCONAZOLE NITRATEActive
Quantity: 100 mg in 5 g
Code: 4805237NP5
Classification: ACTIB
GLYCERYL ISOSTEARATEInactive
Code: HYE7O27HAO
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYGLYCERYL-3 OLEATEInactive
Code: XRQ165498B
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT