Tretinoin
Tretinoin Gel, USP Tretinoin Cream, USP Rx only For External Use Only. Not For Ophthalmic Use.
Approved
Approval ID
f5ce22e8-1a9b-408c-86ae-4084b7afeca1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-655
Application NumberANDA075264
Product Classification
M
Marketing Category
C73584
G
Generic Name
tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2011
FDA Product Classification
INGREDIENTS (9)
TRETINOINActive
Quantity: 0.25 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
tretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-804
Application NumberANDA075265
Product Classification
M
Marketing Category
C73584
G
Generic Name
tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2011
FDA Product Classification
INGREDIENTS (9)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRETINOINActive
Quantity: 0.5 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
tretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-763
Application NumberANDA075529
Product Classification
M
Marketing Category
C73584
G
Generic Name
tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2011
FDA Product Classification
INGREDIENTS (5)
TRETINOINActive
Quantity: 0.25 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
BRUCINE SULFATEInactive
Code: KY7O12XPOQ
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
TERT-BUTYL ALCOHOLInactive
Code: MD83SFE959
Classification: IACT