Tretinoin
TRETINOIN CREAM USP, 0.025%
Approved
Approval ID
c7860dcd-91b0-44e0-98d6-a843b16457e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0651
Application NumberNDA020404
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2019
FDA Product Classification
INGREDIENTS (11)
TRETINOINActive
Quantity: 0.25 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PPG-12/SMDI COPOLYMERInactive
Code: 1BK9DDD24E
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
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