Urea Cream 41%
Urea Cream 41%
Approved
Approval ID
e323df93-f8cc-d436-e053-2a95a90a0a74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
Canton Laboratories
DUNS: 079589614
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 Code69437-341
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateOctober 26, 2023
Generic NameUrea
INGREDIENTS (10)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CETEARETH-25Inactive
Code: 8FA93U5T67
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
UREAActive
Quantity: 410 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
CETEARETH-6Inactive
Code: 2RJS3559D3
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT