METROGEL
These highlights do not include all the information needed to use METROGEL, 1% safely and effectively. See full prescribing information for METROGEL, 1% METROGEL® (metronidazole) topical gel Initial U.S. Approval 1963
Approved
Approval ID
ab3a8a2d-714a-4beb-af8a-99bc3ac3ebbe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Galderma Laboratories, L.P.
DUNS: 047350186
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
metronidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0299-3820
Application NumberNDA021789
Product Classification
M
Marketing Category
C73594
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (9)
METRONIDAZOLEActive
Quantity: 10 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
betadexInactive
Code: JV039JZZ3A
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
niacinamideInactive
Code: 25X51I8RD4
Classification: IACT
phenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT