FDA.reportPublic FDA data

Durisan Hand Sanitizer Wipes

Manufacturer
Sanit Technologies LLC | Durisan
Effective date
2020-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:33:54

Label at a glance#

ProductDurisan Hand Sanitizer Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

• To decrease bacteria on the skin.

Dosage and administration

•Rub thoroughly over all surfaces of both hands. •Rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

  • For external use only.
  • Stop use and consult a doctor if irritation or redness develops.
  • Keep out of eyes. In case of contact, flush eyes water.

Uses

INDICATIONS & USAGE SECTION

• To decrease bacteria on the skin.

Directions

DOSAGE & ADMINISTRATION SECTION

•Rub thoroughly over all surfaces of both hands.
•Rub hands together briskly until dry.

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 immediately.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

water, cetrimonium chloride,laurtrimonium chloride, dihydroxyethyl cocamine oxide,glycereth-17 cocoate, propylene glycol, diazolidinyl urea, methylparaben, propyl paraben, citric acid, dihydroxypropyl PEG-5 linoleammonium chloride.

Product Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
71120-111-012021-07-23C16284748780-1c7ccaba7-1578-fd44-e053-dadaa90aa01b160ct Hand Sanitizer Wipes
71120-111-022021-07-23C16284748780-1c7ccaba7-1578-fd44-e053-dadaa90aa01b160ct Hand Sanitizer Wipes
71120-111-032021-07-23C16284748780-1c7ccaba7-1578-fd44-e053-dadaa90aa01b160ct Hand Sanitizer Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71120-111-01Durisan Hand Sanitizer Wipes160 mL in 1 CONTAINERLIQUID1602
71120-111-02Durisan Hand Sanitizer Wipes80 mL in 1 CONTAINERLIQUID802
71120-111-03Durisan Hand Sanitizer Wipes240 mL in 1 CONTAINERLIQUID2402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71120-111DURISAN HAND SANITIZER WIPES (BENZALKONIUM CHLORIDE) LIQUID [SANIT TECHNOLOGIES LLC]2Legacy NDC, 3 package rows20201119_de4c80b0-3835-4099-a3b9-06894e30e3f1.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71120-11171120-111-01, 71120-111-02, 71120-111-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
GLYCERETH-17 COCOATE3057VPT0KCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE0Y0NQR2GH1IACT

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
c554d002-a44d-447b-b2eb-c89420fcdb1dde4c80b0-3835-4099-a3b9-06894e30e3f12020-11-11WarningsExact identifier
spl id: c554d002-a44d-447b-b2eb-c89420fcdb1d
spl set id: de4c80b0-3835-4099-a3b9-06894e30e3f1

Reported adverse events (FAERS/openFDA)#

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