FDA.reportPublic FDA data

Purifi Hand Sanitizer

Manufacturer
Purifi LLC
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:09

Label at a glance#

ProductPurifi Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Storage and handling

Other information Store above 32°F (0°C) and below 100°F (38.8°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses

Hand sanitizing to help reduce bacteria on the skin

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

​Stop use and ask a doctor ifirritation or redness appears and lasts

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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply liberally to hands and gently rub until dry. Reapply every 6 hours.

STORAGE AND HANDLING SECTION

Other information

Store above 32°F (0°C) and below 100°F (38.8°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

purified water, glycerin, aloe barbadensis leaf juice

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN4
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD4
1049254benzalkonium chloride 0.13 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80659-301-012024-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-022024-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-032024-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-042024-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-052024-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-012022-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-022022-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-032022-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-042022-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-052022-01-31C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-012022-01-28C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-022022-01-28C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-032022-01-28C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-042022-01-28C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-052022-01-28C16284748780-1d6a99b39-e7c0-a426-e053-dadaa90af4c2Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80659-301-01Purifi Hand Sanitizer250 mL in 1 BOTTLE, PLASTICSOLUTION2504
80659-301-02Purifi Hand Sanitizer60 mL in 1 BOTTLE, PLASTICSOLUTION604
80659-301-03Purifi Hand Sanitizer3800 mL in 1 BOTTLE, PLASTICSOLUTION38004
80659-301-04Purifi Hand Sanitizer50 mL in 1 BOTTLE, PLASTICSOLUTION504
80659-301-05Purifi Hand Sanitizer296 mL in 1 BOTTLE, PLASTICSOLUTION2964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80659-301PURIFI HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [PURIFI LLC]4Current NDC, Legacy NDC, 5 package rows20240201_9267069d-4cf5-4e48-a446-7dbebea16bf5.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
80659-30180659-301-01, 80659-301-02, 80659-301-03, 80659-301-04, 80659-301-05

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
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
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
Purifi Hand SanitizerBENZALKONIUM CHLORIDEPurifi LLC9267069d-4cf5-4e48-a446-7dbebea16bf52024-01-31WarningsExact identifier
ndc (package): 80659-301-03
ndc (package): 80659-301-04
ndc (package): 80659-301-02
ndc (package): 80659-301-01
ndc (package): 80659-301-05
ndc (product): 80659-301
ndc11 (package): 80659030101
ndc11 (package): 80659030103
ndc11 (package): 80659030104
ndc11 (package): 80659030105
ndc11 (package): 80659030102
spl id: 103dc041-e75d-b464-e063-6394a90ab4d8
spl set id: 9267069d-4cf5-4e48-a446-7dbebea16bf5

Reported adverse events (FAERS/openFDA)#

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