Hand Sanitizer

Manufacturer
Northmed SIA
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:31

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

1000 mL (33.8 fl. oz.) NDC: 78522-104-00

RPPE 1L refill bottleRPPE 1L refill bottle

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78522-100-002023-01-30C16284748780-1f386c64a-3514-0266-e053-dadaa90a7c1ab6b264a8-a975-0b61-e053-2995a90a1d63
78522-104-002023-01-30C16284748780-1f386c64a-3514-0266-e053-dadaa90a7c1ab6b264a8-a975-0b61-e053-2995a90a1d63

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78522-100-00Hand Sanitizer59 mL in 1 BOTTLE, SPRAYSPRAY592
78522-104-00Hand Sanitizer1000 mL in 1 BOTTLELIQUID10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78522-100HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID HAND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [NORTHMED SIA]2Legacy NDC, 1 package rows20211028_b6b264a8-a975-0b61-e053-2995a90a1d63.zip
78522-104HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID HAND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [NORTHMED SIA]2Legacy NDC, 1 package rows20211028_b6b264a8-a975-0b61-e053-2995a90a1d63.zip

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
78522-10078522-100-00
78522-10478522-104-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
cf4a726e-3ea4-53b5-e053-2995a90a5f27b6b264a8-a975-0b61-e053-2995a90a1d632021-10-26WarningsExact identifier
spl id: cf4a726e-3ea4-53b5-e053-2995a90a5f27
spl set id: b6b264a8-a975-0b61-e053-2995a90a1d63

Reported adverse events (FAERS/openFDA)#

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