UREA
Urea 40% Cream
Approved
Approval ID
f57446a6-f0c2-41a3-e053-2a95a90a0b22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2023
Manufacturers
FDA
Palmetto Pharmaceuticals Inc.
DUNS: 963291864
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
UREA
PRODUCT DETAILS
NDC Product Code68134-801
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateFebruary 24, 2023
Generic NameUREA
INGREDIENTS (11)
CARBOMER INTERPOLYMER TYPE A (55000 CPS)Inactive
Code: 59TL3WG5CO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DIMETHYL ISOSORBIDEInactive
Code: SA6A6V432S
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
UREAActive
Quantity: 400 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT