FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
BioSyn Inc | Toll Solutions | Higley Industries, Ins
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:40:53

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin. As a wound antiseptic to help prevent bacterial contamination in cuts, burns, scrapes, lacerations, and skin infections.

Dosage and administration

Pump onto hands as needed. Rub briskly until dry. Apply to wounds 3 times per day after cleaning. Allow to dry. May be bandaged once dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial and First Aid Antiseptic

Uses:

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on the skin. As a wound antiseptic to help prevent bacterial contamination in cuts, burns, scrapes, lacerations, and skin infections.

Warnings:

WARNINGS SECTION

For External Use Only

When Using This Product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of eye contact, flush eyes with water

Discontinue Use if

OTC - STOP USE SECTION

irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Pump onto hands as needed. Rub briskly until dry.
  • Apply to wounds 3 times per day after cleaning. Allow to dry. May be bandaged once dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colalipid C, Green Tea Leaf Extract, Hydroxyethyl Cellulose, Sodium Bicarbonate, Water

Principal Dislpay Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 gallon NDC:79832-301-80 1 gallon label1 gallon label

16oz NDC:79832-301-16 16oz label16oz label

8oz NDC:79832-301-08 8oz label8oz 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
79832-30179832-301-80, 79832-301-16, 79832-301-08

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
GREEN TEA LEAFW2ZU1RY8B0IACT

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
f1f5dc41-a6ea-a694-e053-2995a90a1eb3b865dc50-ea2d-09e8-e053-2995a90aeb1b2023-01-10WarningsExact identifier
spl id: f1f5dc41-a6ea-a694-e053-2995a90a1eb3
spl set id: b865dc50-ea2d-09e8-e053-2995a90aeb1b

Reported adverse events (FAERS/openFDA)#

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