Xurea
Xurea
Approved
Approval ID
bfbd3916-dfef-4192-a99e-ee9f97a3f532
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2019
Manufacturers
FDA
NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
DUNS: 967054623
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 Code72678-034
Product Classification
G
Generic Name
Urea
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 24, 2019
FDA Product Classification
INGREDIENTS (12)
UREAActive
Quantity: 390 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
MELALEUCA ALTERNIFOLIA LEAFInactive
Code: G43C57162K
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT