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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42808-204
Product Classification
G
Generic Name
Urea
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 23, 2023
FDA Product Classification
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