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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68134-801
Product Classification
G
Generic Name
UREA
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 24, 2023
FDA Product Classification
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