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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-515
Application NumberNDA020475
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 30, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-513
Application NumberNDA020475
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 30, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-514
Application NumberNDA020475
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 30, 2023
FDA Product Classification
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