Carac
(fluorouracil cream)
Approved
Approval ID
6795f2b1-1381-4a4f-ad34-2c28ebd1cfaf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2021
Manufacturers
FDA
Bausch Health US, LLC
DUNS: 831922468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluorouracil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-5200
Application NumberNDA020985
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluorouracil
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 17, 2021
FDA Product Classification
INGREDIENTS (14)
fluorouracilActive
Quantity: 5 mg in 1 g
Code: U3P01618RT
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
methyl gluceth-20Inactive
Code: J3QD0LD11P
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
trolamineInactive
Code: 9O3K93S3TK
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT