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Provon Antimicrobial Foam Handwash

2% GOJO ADX/LTX

Approved
Approval ID

46dd136c-d569-0450-e054-00144ff8d46c

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 Code0116-8500
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)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 20 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT

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Provon Antimicrobial Foam Handwash - FDA Drug Approval Details