FDA.reportPublic FDA data

Bortek Antibacterial Hand Wash

Manufacturer
Bortek Industries
Effective date
2022-09-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:53:03

Label at a glance#

ProductBortek Antibacterial Hand Wash
Active ingredientCHLOROXYLENOL
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Chloroxylenol 0.3% 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 eye contact, flush 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

  • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
  • Wash both hands thoroughly for 15 seconds.
  • Rinse under running water and dry thoroughly.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, Phenoxyethanol, Isopropyl Alcohol, Fragrance, Citric Acid, FD&C Red 4

SPL UNCLASSIFIED SECTION

800.626.7835

BortekShop.com

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bortek® INDUSTRIES, INC.

Chloroxylenol 0.3%

ANTIBACTERIAL FOAMING HAND WASH

33.8 FL OZ (1000 mL)

1-Antibacterial Handsoap- 81731-5081-Antibacterial Handsoap- 81731-508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81731-50881731-508-10, 81731-508-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT
CHLOROXYLENOL0F32U78V2QACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO DIETHANOLAMIDE92005F972DIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT

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
e99adbfd-c374-0521-e053-2a95a90afba1bfcbdb29-05d2-41d0-e053-2995a90a42362022-09-26WarningsExact identifier
spl id: e99adbfd-c374-0521-e053-2a95a90afba1
spl set id: bfcbdb29-05d2-41d0-e053-2995a90a4236

Reported adverse events (FAERS/openFDA)#

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