Tretinoin
Tretinoin Cream, USP Rx only For External Use Only. Not For Ophthalmic Use.
Approved
Approval ID
ababee41-4f21-44d4-b139-02735fd950ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 18, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code55045-3691
Application NumberANDA075213
Product Classification
M
Marketing Category
C73584
G
Generic Name
tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 18, 2013
FDA Product Classification
INGREDIENTS (9)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
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
TRETINOINActive
Quantity: 1 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