Tretinoin
These highlights do not include all the information needed to use TRETINOIN Gel safely and effectively. See full prescribing information for TRETINOIN Gel. TRETINOIN Gel, 0.05%For topical use Initial U.S. Approval: 1973
Approved
Approval ID
c5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2021
Manufacturers
FDA
Obagi Cosmeceuticals LLC
DUNS: 790553353
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62032-413
Application NumberNDA022070
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2021
FDA Product Classification
INGREDIENTS (16)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
ISOBUTYLPARABENInactive
Code: 0QQJ25X58G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OCTOXYNOL-9Inactive
Code: 7JPC6Y25QS
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
TRETINOINActive
Quantity: 0.05 g in 100 g
Code: 5688UTC01R
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
MARINE COLLAGEN, SOLUBLEInactive
Code: 8JC99XGU4W
Classification: IACT