FDA.reportPublic FDA data

DuroKlean Hand Sanitizing Wipe

Manufacturer
NuGenTec
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:21

Label at a glance#

ProductDuroKleen Sanitizing Wipe
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Rub cloth product on hands to cover and wet all surfaces. Allow to dry without wiping Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.10%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer, Antibacterial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub cloth product on hands to cover and wet all surfaces. Allow to dry without wiping
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrogen peroxide, Ztrex 72 MUP, purified water USP, non-woven cloth

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DuroKlean FrontDuroKlean FrontDuroklean RearDuroklean Rear100 count in one canister NDC: 77368-911-10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77368-912-072021-07-23C16284748780-1c7ccaba7-240f-fd44-e053-dadaa90aa01bDuroKleen Sanitizing Wipe
77368-912-102021-07-23C16284748780-1c7ccaba7-240f-fd44-e053-dadaa90aa01bDuroKleen Sanitizing Wipe
77368-912-202021-07-23C16284748780-1c7ccaba7-240f-fd44-e053-dadaa90aa01bDuroKleen Sanitizing Wipe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77368-912-07DuroKleen Sanitizing Wipe70 in 1 PACKAGECLOTH702
77368-912-07DuroKleen Sanitizing Wipe172 mL in 1 PACKAGECLOTH1722
77368-912-10DuroKleen Sanitizing Wipe245 mL in 1 PACKAGECLOTH2452
77368-912-10DuroKleen Sanitizing Wipe100 in 1 CANISTERCLOTH1002
77368-912-20DuroKleen Sanitizing Wipe490 mL in 1 PACKAGECLOTH4902
77368-912-20DuroKleen Sanitizing Wipe200 in 1 CANISTERCLOTH2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77368-912DUROKLEEN SANITIZING WIPE (BENZALKONIUM CHLORIDE) CLOTH [NUGENTEC]2Legacy NDC, 6 package rows20210127_b8e69d83-ef79-b20c-e053-2995a90a0d50.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77368-91277368-912-10, 77368-912-20, 77368-912-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYLTETRADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEN7BH1NTV97IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
b9bf62d7-c681-b34a-e053-2a95a90a48cab8e69d83-ef79-b20c-e053-2995a90a0d502021-01-25WarningsExact identifier
spl id: b9bf62d7-c681-b34a-e053-2a95a90a48ca
spl set id: b8e69d83-ef79-b20c-e053-2995a90a0d50

Reported adverse events (FAERS/openFDA)#

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