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Foaming Hand

Vestis 224.000/224AA Sanitizing Foaming Hand Soap

Approved
Approval ID

3b4dbfd0-f275-3502-e063-6294a90a8486

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

VERITIV OPERATING COMPANY

DUNS: 006989982

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzalkonium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71897-224
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (10)

LAURAMIDOPROPYLAMINE OXIDEInactive
Code: I6KX160QTV
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 1.3 mg in 1 mL
Code: F5UM2KM3W7
Classification: ACTIB
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MYRISTAMIDOPROPYLAMINE OXIDEInactive
Code: 3HSF539C9T
Classification: IACT
TETRASODIUM EDTAInactive
Code: MP1J8420LU
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal Display Panel

vestis ®

NSF

Nonfood Compounds Program Listed E2 157038

Antibacterial

E2 Sanitizing

Foaming Hand Soap

Fragrance Free

33.8 FL OZ (1.05 QT) 1 L

mm01mm02

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Uses

for handwashing to decrease bacteria on the skin

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/1/2025

Adverse Reaction

Distributed by: Vestis

1035 Alpharetta Street

Suite 2100

Roswell, GA 30075

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active Ingredient

Benzalkonium chloride 0.13 %

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Antibacterial

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

For external use only: hands only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/1/2025

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes with water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Directions

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, citric acid, tetrasodium EDTA, sodium benzoate

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/1/2025

Claim

Product is NSF registered for use as a hand sanitizer in and around fool processing areas.

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Foaming Hand - FDA Drug Approval Details