CEM-Urea
CEM-UREA TM PRE-FILLED APPLICTOR REV.1.0
Approved
Approval ID
697b1730-b716-444f-8671-934f47ae21bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2011
Manufacturers
FDA
PruGen, Inc.
DUNS: 929922750
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 Code42546-100
Product Classification
G
Generic Name
urea
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 16, 2011
FDA Product Classification
INGREDIENTS (9)
UREAActive
Quantity: .45 mL in 1 mL
Code: 8W8T17847W
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%)Inactive
Code: 7Q6P4JN1QT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT