FDA.reportPublic FDA data

Hand Sanitizer

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#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure19 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.
  • ­­­­Keep out of eyes. In case of contact, flush eyes water.
  • Stop use and consult a doctor if irritation or redness develops.

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, methyl paraben, propylparaben, citric acid, dihydroxypropyl, PEG-5 linoleammonium.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71120-112-012021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-022021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-032021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-042021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-052021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-062021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-072021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-082021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-092021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-102021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer
71120-112-112021-07-23C16284748780-1c7ccaba7-2aea-fd44-e053-dadaa90aa01b18ml Hand Sanitizer Credit Card Sprayer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71120-112-01Hand Sanitizer18 mL in 1 CONTAINERLIQUID182
71120-112-02Hand Sanitizer24 in 1 PACKAGELIQUID242
71120-112-02Hand Sanitizer18 mL in 1 CONTAINERLIQUID182
71120-112-03Hand Sanitizer18 mL in 1 CONTAINERLIQUID182
71120-112-03Hand Sanitizer48 in 1 PACKAGELIQUID482
71120-112-04Hand Sanitizer50 mL in 1 CONTAINERLIQUID502
71120-112-05Hand Sanitizer1000 mL in 1 CONTAINERLIQUID10002
71120-112-06Hand Sanitizer550 mL in 1 CONTAINERLIQUID5502
71120-112-07Hand Sanitizer250 mL in 1 CONTAINERLIQUID2502
71120-112-08Hand Sanitizer300 mL in 1 CONTAINERLIQUID3002
71120-112-09Hand Sanitizer3785 mL in 1 CONTAINERLIQUID37852
71120-112-10Hand Sanitizer118 mL in 1 BOTTLE, SPRAYLIQUID1182
71120-112-11Hand Sanitizer236 mL in 1 BOTTLE, SPRAYLIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71120-112HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [SANIT TECHNOLOGIES LLC]2Legacy NDC, 13 package rows20201119_b5d53bb1-f50b-484c-b021-55f0700097a3.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
71120-11271120-112-01, 71120-112-04, 71120-112-05, 71120-112-06, 71120-112-07, 71120-112-08, 71120-112-09, 71120-112-10, 71120-112-11, 71120-112-02, 71120-112-03

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
0b6b5faf-b176-4175-8ae6-fa263bd92061b5d53bb1-f50b-484c-b021-55f0700097a32020-11-11WarningsExact identifier
spl id: 0b6b5faf-b176-4175-8ae6-fa263bd92061
spl set id: b5d53bb1-f50b-484c-b021-55f0700097a3

Reported adverse events (FAERS/openFDA)#

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