UREA
Approved
Approval ID
e4516083-fb4d-4550-a6d7-31fb5bb93a24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2023
Manufacturers
FDA
Exact-Rx, Inc.
DUNS: 137953498
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 Code42808-202
Product Classification
G
Generic Name
UREA
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 23, 2023
FDA Product Classification
INGREDIENTS (14)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
UREAActive
Quantity: 450 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT