Tretinoin
These highlights do not include all the information needed to use Tretinoin Gel Microsphere safely and effectively. See full prescribing information for Tretinoin Gel Microsphere. Tretinoin Gel Microsphere, 0.1%, 0.08%, and 0.04%
Approved
Approval ID
d3c528d2-429d-4f37-9ebf-eee8b9fd3050
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tretinoin
PRODUCT DETAILS
NDC Product Code68682-515
Application NumberNDA020475
Marketing CategoryC73605
Route of AdministrationTOPICAL
Effective DateOctober 30, 2023
Generic NameTretinoin
INGREDIENTS (12)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
TRETINOINActive
Quantity: 0.8 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PPG-20 METHYL GLUCOSE ETHER DISTEARATEInactive
Code: 0057334FAB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
Tretinoin
PRODUCT DETAILS
NDC Product Code68682-513
Application NumberNDA020475
Marketing CategoryC73605
Route of AdministrationTOPICAL
Effective DateOctober 30, 2023
Generic NameTretinoin
INGREDIENTS (12)
TRETINOINActive
Quantity: 1 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PPG-20 METHYL GLUCOSE ETHER DISTEARATEInactive
Code: 0057334FAB
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
Tretinoin
PRODUCT DETAILS
NDC Product Code68682-514
Application NumberNDA020475
Marketing CategoryC73605
Route of AdministrationTOPICAL
Effective DateOctober 30, 2023
Generic NameTretinoin
INGREDIENTS (12)
TRETINOINActive
Quantity: 0.4 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
PPG-20 METHYL GLUCOSE ETHER DISTEARATEInactive
Code: 0057334FAB
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT