Urea Cream 40 Percent
Urea 40 Percent Cream
Approved
Approval ID
e28969bc-c3a0-49e5-9947-aee0c6b8b0b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2203
Product Classification
G
Generic Name
Urea
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (8)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
UREAActive
Quantity: 400 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT