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Dyna-Hex 4

Dyna-Hex 32oz Round & Sqaure Bottle

Approved
Approval ID

0a32c299-f7ca-d15c-e063-6294a90af2c1

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 Code0116-1060
Application NumberNDA019127
Product Classification
M
Marketing Category
C73594
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2025
FDA Product Classification

INGREDIENTS (8)

PEG-75 LANOLINInactive
Code: 09179OX7TB
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GLUCONOLACTONEInactive
Code: WQ29KQ9POT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 4 g in 100 mL
Code: MOR84MUD8E
Classification: ACTIB
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
TRIDECYL ALCOHOLInactive
Code: 8I9428H868
Classification: IACT

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Dyna-Hex 4 - FDA Drug Approval Details