FDA.reportPublic FDA data

Bortek Foaming Hand Sanitizer

Manufacturer
Bortek Industries
Effective date
2022-02-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:08:18

Label at a glance#

ProductBortek Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.1% w/w

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • Handwash to decrease bacteria on the skin that can potentially cause disease.
  • Recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product, keep away from eyes. In case of contact, rinse eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation 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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Pump sufficient amount of foam into palm of hand.
  • Rub foam thoroughly over all surfaces of both hands, including the area under the fingernails
  • Allow to dry without wiping

INACTIVE INGREDIENT SECTION

Inactive ingredients

Cetrimonium chloride, lautrimonium chloride, phenoxyethanol, stearalkonium chloride, water.

SPL UNCLASSIFIED SECTION

800.626.7835

BortekShop.com

Distributed by Bortek Industries, Inc., Mechanicsburg, PA 17055

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bortek® INDUSTRIES, INC.

Alcohol Free | Benzalkonium chloride 0.1% Antiseptic

FOAMING HAND SANITIZER

33.8 fl oz (1000 mL)

7-BZK Foaming HS - Pouch 81731-4037-BZK Foaming HS - Pouch 81731-403

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
81731-40381731-403-01, 81731-403-11

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
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARALKONIUM CHLORIDE0OUO26BB88IACT
WATER059QF0KO0RIACT
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
f5163275-0f8e-8c5a-e053-2a95a90ad7c3bfcd5cb8-1030-9274-e053-2a95a90aba7e2023-02-19WarningsExact identifier
spl set id: bfcd5cb8-1030-9274-e053-2a95a90aba7e

Reported adverse events (FAERS/openFDA)#

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