FDA.reportPublic FDA data

Durisan

Manufacturer
Sanit Technologies LLC
Effective date
2020-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:20

Label at a glance#

ProductDurisan
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

Pump onto dry skin. Lather vigorously for 20 seconds. Rinse hands and dry thoroughly.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact eyes with water.

Stop use and consult a doctor if irritation or redness develops.

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

  • Pump onto dry skin. Lather vigorously for 20 seconds.
  • Rinse hands and dry thoroughly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, cocamidopropyl betaine, glycerin, cetrimonium chloride, benzyl alcohol, disodium EDTA, fragrance, benzoic acid, sorbic acid, citric acid, violet 2 (CI 60730)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN1
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD1
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71120-115-012021-07-23C16284748780-1c7ccaba7-1176-fd44-e053-dadaa90aa01b369a1a88-24ed-4dbb-9423-45dc46b89a97

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71120-115-01Durisan300 mL in 1 PACKAGELIQUID3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71120-115DURISAN (BENZALKONIUM CHLORIDE) LIQUID [SANIT TECHNOLOGIES LLC]1Legacy NDC, 1 package rows20201010_369a1a88-24ed-4dbb-9423-45dc46b89a97.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71120-11571120-115-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BENZOIC ACID8SKN0B0MIMIACT
SORBIC ACIDX045WJ989BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
D&C VIOLET NO. 2350KA7O6HKIACT

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
6e4d260e-3b2d-4709-a448-498748980cc7369a1a88-24ed-4dbb-9423-45dc46b89a972020-10-08WarningsExact identifier
spl id: 6e4d260e-3b2d-4709-a448-498748980cc7
spl set id: 369a1a88-24ed-4dbb-9423-45dc46b89a97

Reported adverse events (FAERS/openFDA)#

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