FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Advanced Hygienics LLC | Wisconsin Pharmacal Company
Effective date
2017-05-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:54

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

Pump a small amount of foam onto hands.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimomium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

OTC - QUESTIONS SECTION

Questions?

1-866-443-4509

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

American

Red Cross

Always Ready

Hand Sanitizer

Antibacterial Foaming

Alcohol-Free

Powerful and Long Lasting

Gentle

16.9 FL OZ (500 mL)

container labelcontainer label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN2
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD2
1020365benzalkonium chloride 0.13 % Topical FoamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63002-004-33Hand Sanitizer9.76 mL in 1 BOTTLE, SPRAYSOLUTION9.762
63002-004-50Hand Sanitizer500 mL in 1 BOTTLESOLUTION5002
63002-004-99Hand Sanitizer50 mL in 1 BOTTLESOLUTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63002-004HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [ADVANCED HYGIENICS LLC]2Current NDC, Legacy NDC, 3 package rows20170522_1b225968-aff7-4959-89e1-a8edabb4d670.zip

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
63002-00463002-004-33, 63002-004-99, 63002-004-50

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
POLIHEXANIDE322U039GMFIACT
CAPRYLYL GLUCOSIDEV109WUT6RLIACT
C12-15 PARETH-73XY03A79QHIACT
DIMETHICONE92RU3N3Y1OIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
GLYCERETH-17 COCOATE3057VPT0KCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC1b225968-aff7-4959-89e1-a8edabb4d6702017-05-22WarningsExact identifier
ndc (package): 63002-004-99
ndc (package): 63002-004-50
ndc (package): 63002-004-33
ndc (product): 63002-004
ndc11 (package): 63002000499
ndc11 (package): 63002000433
ndc11 (package): 63002000450
spl id: bfc689ba-d7f8-4c16-9a13-4bd7b859bbf5
spl set id: 1b225968-aff7-4959-89e1-a8edabb4d670

Reported adverse events (FAERS/openFDA)#

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