TRI-LUMA
These highlights do not include all the information needed to use TRI-LUMA Cream safely and effectively. See full prescribing information for TRI-LUMA Cream. TRI-LUMA (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05% for topical use Initial U.S. Approval: 2002
Approved
Approval ID
a35fa709-5eb5-4429-b38f-f1e0019bf0ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 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.
fluocinolone acetonide, hydroquinone, and tretinoin
PRODUCT DETAILS
NDC Product Code0299-5950
Application NumberNDA021112
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2023
Generic Namefluocinolone acetonide, hydroquinone, and tretinoin
INGREDIENTS (17)
HYDROQUINONEActive
Quantity: 40 mg in 1 g
Code: XV74C1N1AE
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
FLUOCINOLONE ACETONIDEActive
Quantity: 0.1 mg in 1 g
Code: 0CD5FD6S2M
Classification: ACTIB
TRETINOINActive
Quantity: 0.5 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
METHYL GLUCETH-10Inactive
Code: N0MWT4C7WH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT