Urea
Urea Nail Gel 45% (in a vehicle containing camphor, menthol and eucalyptus oil) Rx Only
Approved
Approval ID
b58e175d-60e8-4206-ac7a-c67b68ac80f0
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
NDC Product Code42808-204
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateOctober 23, 2023
Generic NameUrea
INGREDIENTS (9)
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
UREAActive
Quantity: 450 mg in 1 mL
Code: 8W8T17847W
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT