Mirvaso
These highlights do not include all the information needed to use MIRVASO safely and effectively. See full prescribing information for MIRVASO.MIRVASO (brimonidine) topical gel Initial U.S. Approval: 1996
Approved
Approval ID
f6a4353f-ae69-4214-901f-e5d42a6fbde7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2022
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.
brimonidine tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0299-5980
Application NumberNDA204708
Product Classification
M
Marketing Category
C73594
G
Generic Name
brimonidine tartrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (9)
BRIMONIDINE TARTRATEActive
Quantity: 5 mg in 1 g
Code: 4S9CL2DY2H
Classification: ACTIB
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)Inactive
Code: HHT01ZNK31
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT