MedPath

Antiseptic Skin Cleanser

XTT CVS 4% CHG 8oz, 8oz CA, 16oz, 16oz CA, 18oz, 18oz CA

Approved
Approval ID

48a814e7-bfe4-5437-e054-00144ff88e88

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 Code0116-0767
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)

GLUCONOLACTONEInactive
Code: WQ29KQ9POT
Classification: IACT
PEG-75 LANOLINInactive
Code: 09179OX7TB
Classification: IACT
TRIDECYL ALCOHOLInactive
Code: 8I9428H868
Classification: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
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
CHLORHEXIDINE GLUCONATEActive
Quantity: 4 g in 100 mL
Code: MOR84MUD8E
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.