Urea Cream 41%
Urea Cream 41%
Approved
Approval ID
ada4d313-1050-4501-9c93-68dfb3a2c9e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Laser Pharmaceuticals, LLC
DUNS: 614417132
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 Code16477-341
Product Classification
G
Generic Name
Urea
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 11, 2023
FDA Product Classification
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
CETEARETH-6Inactive
Code: 2RJS3559D3
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
UREAActive
Quantity: 410 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB