FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
EXPORTADORA IN & OUT S DE RL DE CV | ISMAR SOLUCIONES DINAMICAS S DE RL DE CV
Effective date
2020-07-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:22:53

Label at a glance#

ProductHAND SANITIZER
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin that could cause disease recommended for repetead use

Dosage and administration

put enough product in your palm to cover hands and rub hands together briskly until dry without wiping for children under 6 years of age should be supervised when using germ killa not recommended for infants

Storage and handling

store below 105 F (40C) may discolor certain fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

benzalkonium chloride v/v 1%

Purposes

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

hand sanitizer to decrease bacteria on the skin that could cause disease

recommended for repetead use

Warnings

WARNINGS SECTION

for external use only: hands

flammable, keep away from fire and flame

When using this product

OTC - DO NOT USE SECTION

keep out of eyes, do not use in or near the eyes

in case of contact with eyes, flush thorougly with water

avoid contact with broken skin

do not inhale or ingest

When using this product

OTC - WHEN USING SECTION

keep out of eyes, do not use in or near the eyes

in case of contact with eyes, flush thorougly with water

avoid contact with broken skin

do not inhale or ingest

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation and redness develo

condition persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a posion control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

for children under 6 years of age should be supervised when using germ killa

not recommended for infants

Other information

STORAGE AND HANDLING SECTION

store below 105 F (40C)

may discolor certain fabrics

harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

CMC, Glycerine, Water, Orange oil

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 250 mllabel 250 mlEfficiently kills 99.99% of most illness causing germs

hand sanitizer gel

leaves hands soft

contain moisturizers

paraben free

phtalate free

formaldehyde donor free

250 ml

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
77210-001477210-0014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCERINPDC6A3C0OXIACT
ORANGE OILAKN3KSD11BIACT
WATER059QF0KO0RIACT

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
aed00280-ec65-42a9-e053-2995a90a6e35a9e1d9e0-91cf-0ccb-e053-2a95a90aa7d42020-09-08WarningsExact identifier
spl set id: a9e1d9e0-91cf-0ccb-e053-2a95a90aa7d4

Reported adverse events (FAERS/openFDA)#

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