FDA.reportPublic FDA data

Dirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes

Manufacturer
Yourlink Ltd | MC Healthcare Development Ltd
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:59

Label at a glance#

ProductDirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Peel back the foil seal and pull the center wipe through the slot in the lid. Wet hands thoroughly with product and allow to dry without wiping. Close lid after use to prevent wipes from drying out.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop.
  • 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

  • Peel back the foil seal and pull the center wipe through the slot in the lid.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Close lid after use to prevent wipes from drying out.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl glycosides, Fragrance, Disodium EDTA, 2-Bromo-2-Nitropropane-1,3-diol, 1,2-Benzisothiazolin-3-One

Package Labeling:2 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 wipes2 wipes

Package Labeling:80 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 wipes80 wipes

Package Labeling:40 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40 wipes40 wipes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83142-005-022025-01-30C16284748780-12cef2736-725a-d83d-e063-dadaa90ab31fDirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes
83142-005-402025-01-30C16284748780-12cef2736-725a-d83d-e063-dadaa90ab31fDirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes
83142-005-802025-01-30C16284748780-12cef2736-725a-d83d-e063-dadaa90ab31fDirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83142-005-02Dirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes1 in 1 CARTONCLOTH12
83142-005-02Dirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes2 in 1 PACKETCLOTH22
83142-005-40Dirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes40 in 1 BAGCLOTH402
83142-005-40Dirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes1 in 1 CARTONCLOTH12
83142-005-80Dirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes1 in 1 CARTONCLOTH12
83142-005-80Dirteeze Rough and smooth heavy duty antiseptic hand sanitizer wipes80 in 1 CANISTERCLOTH802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83142-005DIRTEEZE ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER WIPES (BENZALKONIUM CHLORIDE) CLOTH [YOURLINK LTD]2Legacy NDC, 6 package rows20231027_82f5360a-8445-4f5b-a43e-a79432c729ea.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83142-00583142-005-02, 83142-005-40, 83142-005-80

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
BENZISOTHIAZOLINONEHRA0F1A4R3IACT
WATER059QF0KO0RIACT
POLOXALENEV8B3K56SW0IACT
PEG-75 LANOLIN09179OX7TBIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BRONOPOL6PU1E16C9WIACT
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
08aad0f9-dd98-dfeb-e063-6294a90a743282f5360a-8445-4f5b-a43e-a79432c729ea2023-10-26WarningsExact identifier
spl id: 08aad0f9-dd98-dfeb-e063-6294a90a7432
spl set id: 82f5360a-8445-4f5b-a43e-a79432c729ea

Reported adverse events (FAERS/openFDA)#

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