FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Sanit Technologies LLC | Durisan
Effective date
2020-10-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:41

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 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 with 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, propyl paraben, citric acid, dihydroxypropyl PEG-5 linoleammonium chloride.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71120-113-012021-07-23C16284748780-1c7ccaba7-2034-fd44-e053-dadaa90aa01b1000ml Hand Sanitizer Kidney Refill
71120-113-022021-07-23C16284748780-1c7ccaba7-2034-fd44-e053-dadaa90aa01b1000ml Hand Sanitizer Kidney Refill

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71120-113-01Hand Sanitizer1000 mL in 1 PACKAGELIQUID10001
71120-113-02Hand Sanitizer6 in 1 PACKAGELIQUID61
71120-113-02Hand Sanitizer1000 mL in 1 CONTAINERLIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71120-113HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [SANIT TECHNOLOGIES LLC]1Legacy NDC, 3 package rows20201016_23cac5f4-1551-4cae-b40d-0ff5f7bf6c98.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
71120-11371120-113-01, 71120-113-02

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
25cc7210-12a8-47b0-be62-1427a3e001ac23cac5f4-1551-4cae-b40d-0ff5f7bf6c982020-10-06WarningsExact identifier
spl id: 25cc7210-12a8-47b0-be62-1427a3e001ac
spl set id: 23cac5f4-1551-4cae-b40d-0ff5f7bf6c98

Reported adverse events (FAERS/openFDA)#

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