FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
QuadSil Inc | Tri Pac
Effective date
2024-03-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:13:13

Label at a glance#

ProductHAND SANITIZER
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

For Hand Sanitizing.

Dosage and administration

Prime pump, use one pump to cover both hands.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethacone, Crosspolymer, PPG-3, Benzyl Ether Ethylhexanoate, Octadecyldimethyl Trimethoxysilylpropyl Ammonium Chloride.

USES

INDICATIONS & USAGE SECTION

For Hand Sanitizing.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Prime pump, use one pump to cover both hands.

WARNINGS

WARNINGS SECTION

The Human Corona Virus is not COVID-19. For External Use Only. Avoid contacts with eyes. In case of eye contact, flush eyes with water. If irritation or redness develops, stop use. If condition persists for more than 72 hours, contact a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Distributed By: Thor Microbials

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Si + ARMOR
LONG-LASTING ANTIMICROBIAL

HAND SANITIZER

ALCOHOL FREE

KILLS 99.9% OF GERMS &
HUMAN CORONA VIRUS

4-8 HOURS
OF GERM PROTECTION

Softens Hands • 200 Applications
1 fl oz ( 30 ml)

• MADE IN •
• USA •

Principal Display Panel - 30 ml Bottle Label
Principal Display Panel - 30 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN4
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD4
1049228benzalkonium chloride 0.1 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80581-087-012024-05-31C16284748780-11030e365-5b47-111a-e063-dadaa90a10e2HAND SANITIZER
80581-087-012024-01-30C16284748780-11030e365-5b47-111a-e063-dadaa90a10e2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80581-087-01HAND SANITIZER30 mL in 1 BOTTLEGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80581-087HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [QUADSIL INC]4Legacy NDC, 1 package rows20240601_5bb703cd-ff43-4605-a72d-2c78305105d9.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80581-08780581-087-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
TRIPROPYLENE GLYCOL3C8845E7C1IACT

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
e731a905-e26d-4529-af26-b0c01d3f75f15bb703cd-ff43-4605-a72d-2c78305105d92024-03-12WarningsExact identifier
spl id: e731a905-e26d-4529-af26-b0c01d3f75f1
spl set id: 5bb703cd-ff43-4605-a72d-2c78305105d9

Reported adverse events (FAERS/openFDA)#

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