Urea 39.5% with 2% Salicylic Acid
Urea 39.5% Cream with 2% Salicylic Acid
Approved
Approval ID
f7aa7b4f-3cb4-6113-e053-6394a90a4188
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
PureTek Corporation
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Urea, Salicylic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-210
Product Classification
G
Generic Name
Urea, Salicylic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (19)
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
UREAActive
Quantity: 39.5 g in 100 g
Code: 8W8T17847W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SALICYLIC ACIDActive
Quantity: 2 g in 100 g
Code: O414PZ4LPZ
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)Inactive
Code: 86FQE96TZ4
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT