FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Swinton Avenue Trading LTD. Inc. | Vi-Jon, LLC.
Effective date
2021-04-20
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 22:46:02

Label at a glance#

ProductAntibacterial Foam
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

Handwash to help reduce bacteria that potentially can cause disease.

Dosage and administration

Wet hands, apply soap, rub hand together vigorously for at least 20 seconds. Rinse and dry hand thoroughly with a disposable paper towel.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Handwash to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops.  If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek immediate medical attention or call a poison control center.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands, apply soap, rub hand together vigorously for at least 20 seconds. Rinse and dry hand thoroughly with a disposable paper towel.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Lauramine Oxide, Cocamidopropyl Betaine, PEG-150 Distearate, Aloe Barbadensis Leaf Juice, Cocamide MEA, Citric Acid, Tetrasodium EDTA, DMDM Hydantoin

Additional rear label text for manual dispensers

SPL UNCLASSIFIED SECTION

HIGHMARK MANUAL DISPENSER REFILL

MANUAL DISPENSER REFILL

ANTIMICROBIAL FOAM SOAP

FRAGRANCE FREE

Distributed by: Office Depot, LLC

6600 N. Military Trail, Boca Raton, FL 33496 USA

Highmark is a trademark or requisted trademark of OMX, Inc.

©2021 Office Depot, LLC.  All Rights Reserved/

Made in USA woth foreign and domestic materials

Questions? Call 1-877-674-0688

40.6 FL OZ (1200 mL)

L0019535BA/000/00

Item 9909824

Additional rear label text for automated refill

SPL UNCLASSIFIED SECTION

HM

HIGHMARK

AUTOMATED DISPENSER REFILL

ANTIMICROBIAL FOAM SOAP

FRAGRANCE FREE

Distributed by: Office Depot, LLC

6600 N. Military Trail, Boca Raton, FL 33496 USA

Highmark is a trademark or registered trade of OMX, inc.

© 2021 Office Depot, LLC. All Rights Reserved.

Made in USA with foreign and domestic materials

Question?  Call 1-877-674-0688

40.6 FL OZ (1200 mL)

L0019536BA

5000011614/000/00

ITEM 9931373

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HM

MANUAL DISPENSER REFILL

ANTIMICROBIAL

FOAM SOAP

FRAGRANCE FREE

40.6 FL OZ (1200 mL)

L0019535FA

5000011610/000/00

ITEM 9909824

image descriptionimage description

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HM

AUTOMATED DISPENSER REFILL

ANTIMICROBIAL

FOAM SOAP

FRAGRANCE FREE

40.6 FL OZ (1200 mL)

L0019536FA

5000011613/000/00

ITEM 9931373

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62440-572-372023-12-04C16284748780-1f386c649-d319-0266-e053-dadaa90a7c1aHighMark Antibacterial Foam Soap 572.000/572AB-AC
62440-572-372023-01-30C16284748780-1f386c649-d319-0266-e053-dadaa90a7c1aHighMark Antibacterial Foam Soap 572.000/572AB-AC

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62440-57262440-572-37

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
DMDM HYDANTOINBYR0546TOWIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0bb6ce39-b784-86ce-e063-6294a90a4c84f5eac265-3a7b-4021-8087-8cec9b840b262023-12-04WarningsExact identifier
spl set id: f5eac265-3a7b-4021-8087-8cec9b840b26

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.