CliniClean
4% HR Pharma 4-oz Foamer
Approved
Approval ID
f8346bd2-72af-e396-e053-6294a90ab602
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 30, 2025
Manufacturers
FDA
Xttrium Laboratories, Inc.
DUNS: 007470579
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorhexidine Gluconate 4%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0116-0901
Application NumberNDA019125
Product Classification
M
Marketing Category
C73594
G
Generic Name
Chlorhexidine Gluconate 4%
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2025
FDA Product Classification
INGREDIENTS (9)
PEG-75 LANOLINInactive
Code: 09179OX7TB
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIDECYL ALCOHOLInactive
Code: 8I9428H868
Classification: IACT
GLUCONOLACTONEInactive
Code: WQ29KQ9POT
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 4 g in 100 mL
Code: MOR84MUD8E
Classification: ACTIB
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT