FDA.reportPublic FDA data

Total Sanitizer Alcohol Free Antiseptic Hand Sanitizer

Manufacturer
Total Sanitizer, LLC
Effective date
2021-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:11

Label at a glance#

ProductTotal Sanitizer Alcohol Free Antiseptic Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Pump a small amount into palm of hand. Wet hands thoroughly with product and allow to dry without wiping. Rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

in eyes. If contact occurs, flush eyes 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, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pump a small amount into palm of hand.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Rub hands together briskly until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Lauramidopropyl Betaine, Aloe Vera, Propylene glycol, Triethylene glycol, Polysorbate-20

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80463-004-002023-01-30C16284748780-1f386c64a-018a-0266-e053-dadaa90a7c1aTotal Sanitizer Alcohol-Free Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80463-004-00Total Sanitizer Alcohol Free Antiseptic Hand Sanitizer50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80463-004TOTAL SANITIZER ALCOHOL FREE ANTISEPTIC HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [TOTAL SANITIZER, LLC]1Legacy NDC, 1 package rows20210217_bb7666e1-ae8a-96b0-e053-2a95a90a76dc.zip

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
80463-00480463-004-00

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
WATER059QF0KO0RIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIETHYLENE GLYCOL3P5SU53360IACT
POLYSORBATE 207T1F30V5YHIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
bb7666e1-ae8b-96b0-e053-2a95a90a76dcbb7666e1-ae8a-96b0-e053-2a95a90a76dc2021-02-16WarningsExact identifier
spl id: bb7666e1-ae8b-96b0-e053-2a95a90a76dc
spl set id: bb7666e1-ae8a-96b0-e053-2a95a90a76dc

Reported adverse events (FAERS/openFDA)#

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