Urea Cream 40%
Urea Cream 40%
Approved
Approval ID
0ce643e9-cf13-4b51-8ffd-8d5636d73e51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2023
Manufacturers
FDA
Akron Pharma Inc.
DUNS: 067878881
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 Code71399-8456
Product Classification
G
Generic Name
Urea
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 3, 2023
FDA Product Classification
INGREDIENTS (10)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
UREAActive
Quantity: 400 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT