ANTISEPTIC SKIN CLEANSER
Dyna-Hex 4: 4oz FM, 8oz, 16oz, 18oz, 32oz, 1 Gallon
Approved
Approval ID
9f6342f7-faa3-4d23-a860-054d04cb8d42
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0116-1061
Application NumberNDA019125
Product Classification
M
Marketing Category
C73594
G
Generic Name
CHLORHEXIDINE GLUCONATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2025
FDA Product Classification
INGREDIENTS (9)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIDECYL ALCOHOLInactive
Code: 8I9428H868
Classification: IACT
GLUCONOLACTONEInactive
Code: WQ29KQ9POT
Classification: IACT
PEG-75 LANOLINInactive
Code: 09179OX7TB
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 4 g in 100 mL
Code: MOR84MUD8E
Classification: ACTIB
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT