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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0299-5950
Application NumberNDA021112
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluocinolone acetonide, hydroquinone, and tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2023
FDA Product Classification
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