FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Point One International, Ltd. | Northmed SIA
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:30:31

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Storage and handling

Should not be sotred below 41F/5C or above 104F/40C.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (.20%). Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic. Hand Sanitizer.

INDICATIONS & USAGE SECTION

Sanitizer to help reduce bacteria on hands. Recommended for repeated use.

WARNINGS SECTION

For external use only.

STORAGE AND HANDLING SECTION

Should not be sotred below 41F/5C or above 104F/40C.

OTC - DO NOT USE SECTION

Do not use in or near eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and rendess develop and persists for more than 72 hours.

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

Apply to hands and rub into the surface of the hands until completely absorbed.

INACTIVE INGREDIENT SECTION

Water, Glycerin, Panthenol, Aloe Vera, Tetrasodium Glutamate Diacetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33.8 fl. oz. 1000ml. NDC: 78522-104-00

1000ml label1000ml label

2 fl. oz. 59ml. NDC: 78522-100-00 59ml label59ml label

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
81207-01181207-011-01, 81207-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERINPDC6A3C0OXIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
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
e34c9bb4-1483-c99f-e053-2a95a90a4ff4bd9fe98c-6f10-f1c7-e053-2a95a90a3ba22022-07-08WarningsExact identifier
spl set id: bd9fe98c-6f10-f1c7-e053-2a95a90a3ba2

Reported adverse events (FAERS/openFDA)#

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