Dyna-Hex 2
Dyna-Hex 2% Square
Approved
Approval ID
0c808ebd-1bf7-175d-e063-6294a90ae7df
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 2%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0116-1022
Application NumberNDA019422
Product Classification
M
Marketing Category
C73594
G
Generic Name
Chlorhexidine Gluconate 2%
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2025
FDA Product Classification
INGREDIENTS (7)
CHLORHEXIDINE GLUCONATEActive
Quantity: 20 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT