FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Swinton Avenue Trading LTD. Inc. | Vi-Jon, LLC.
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:03:41

Label at a glance#

ProductHand Sanitizer Fragrance Free
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

To decrease bacteria on the skin that could cause disease Recommended for repeated use

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Warnings

WARNINGS SECTION

FLAMMABLE, keep away from fire and flame

For external use only

When using this product

OTC - WHEN USING SECTION

do not use in or near eyes   

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 thoroughly with product and allow to dry without wiping.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, PEG-12 Dimethicone, Glycerin, Caprylic/Capric Triglyceride, Isopropyl Myristate

Additional rear label text for manual dispensers

SPL UNCLASSIFIED SECTION

HIGHMARK MANUAL DISPENSER REFILL

FOAM HAND SANITIZER

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

33.9 FL OZ (1000 mL)

L0019531BA/000/00

Alcohol permit SDS-MO-15036, DSP-MO-28, DSP-MO-34

Item 9607759

Additional rear label text for automated refill

SPL UNCLASSIFIED SECTION

HM

HIGHMARK

AUTOMATED DISPENSER REFILL

FOAM HAND SANITIZER

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

L0019532BA

5000011620/000/00

Alcohol permit SDS-MO-15036, DSP-MO-28, DSP-MO-34

Item 9989288

principal display for Manual Dispenser Refill

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HM

MANUAL DISPENSER REFILL

FOAM HAND

SANITIZER

FRAGRANCE FREE

33.9 FL OZ (1000mL)

L0019531FA

5000011616/000/00

ITEM 9607759

image descriptionimage description

principal display panel for automated dispenser refill

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HM

AUTOMATED DISPENSER REFILL

FOAM HAND

SANITIZER

FRAGRANCE FREE

33.9 FL OZ (1000 mL)

L0019532FA

5000011619/000/00

ITEM 9989288

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62440-701-862023-12-04C16284748780-1d6a99b39-cd77-a426-e053-dadaa90af4c2HighMark Foam Hand Sanitizer Fragrance Free 701.000/701AA
62440-701-862022-01-28C16284748780-1d6a99b39-cd77-a426-e053-dadaa90af4c2HighMark Foam Hand Sanitizer Fragrance Free 701.000/701AA

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62440-70162440-701-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-12 DIMETHICONEZEL54N6W95IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATE/CAPRATEG7515SW10NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

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
0bb72367-6193-52eb-e063-6394a90a4dcf12834782-de0b-4836-bc63-7dd1d49e83fb2023-12-04WarningsExact identifier
spl set id: 12834782-de0b-4836-bc63-7dd1d49e83fb

Reported adverse events (FAERS/openFDA)#

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