FDA.reportPublic FDA data

PureLab Hand Sanitizer

Manufacturer
Bexel Internacional, S.A. de C.V.
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:18:52

Label at a glance#

ProductPureLab Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

For hand-washing to decrease bacteria on the skin, only when water is not available.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Anticeptic

Uses

INDICATIONS & USAGE SECTION

For hand-washing to decrease bacteria on the skin, only when water is not available.

Warnings

WARNINGS SECTION

For external use only

Flammable--Keep away from fire and flames

When using this product

OTC - WHEN USING SECTION

do not get into eyes if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation and redness develop.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

Do not store above 105°F (40°C). May discolor certain wood surface.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

water, carbomer, triethanolamine, propylene glycol, tocopheryl acetate, aloe barbadensis.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleBottle2Bottle2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79785-00079785-000-01

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB

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
d66dcc42-4667-6953-e053-2995a90a3e13ac8a0c28-b323-0661-e053-2a95a90a0b202022-01-25WarningsExact identifier
spl set id: ac8a0c28-b323-0661-e053-2a95a90a0b20

Reported adverse events (FAERS/openFDA)#

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