FDA.reportPublic FDA data

Zaliex Antiseptic Hand

Manufacturer
SAS Healthcare Inc | Artemis Bio-Solutions Inc.
Effective date
2012-09-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:33:02

Label at a glance#

ProductZaliex Antiseptic Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand washing to decrease bacteria on the skin Recommended for repeated use

Dosage and administration

Pump a small amount of foam into palm of hand Run thoroughly over all surfaces of both hands for 15 seconds Rinse with potable water

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses:

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings:

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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 a small amount of foam into palm of hand
  • Run thoroughly over all surfaces of both hands for 15 seconds
  • Rinse with potable water

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water (aqua), coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide.

Manufactured for:

SPL UNCLASSIFIED SECTION

Zaliex

Suite 210, 4 Robert Speck Parkway,

Mississauga, Ontario, L4Z1S1, Canada

Zaliex Antiseptic Foam Hand Soap 250ml | Zaliex Antiseptic Foam Hand Soap 550ml (76452-002-01) | Zaliex Antiseptic Foam Hand Soap 1000ml (76452-002-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRICLOSAN FREE


Zaliex
Antiseptic Foam
HAND SOAP

MOISTURIZES * LEAVES SKIN SOFT

Eliminates 99.999%
Of Most Common Germs That May Cause Illness

8.4 fl oz (250 ml)
Environmentally Friendly

Zaliex250mla
Zaliex250mla
Zaliex250mlb
Zaliex250mlb





DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN4
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY4
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76452-002-002020-01-31C16284748780-19d75b9d0-b3e0-f424-e053-dadaa90a57ceZaliex Antiseptic Foam Hand Soap
76452-002-012020-01-31C16284748780-19d75b9d0-b3e0-f424-e053-dadaa90a57ceZaliex Antiseptic Foam Hand Soap
76452-002-022020-01-31C16284748780-19d75b9d0-b3e0-f424-e053-dadaa90a57ceZaliex Antiseptic Foam Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76452-002-00Zaliex Antiseptic Hand250 mL in 1 BOTTLESOAP2504
76452-002-01Zaliex Antiseptic Hand550 mL in 1 BOTTLESOAP5504
76452-002-02Zaliex Antiseptic Hand1000 mL in 1 BOTTLESOAP10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76452-002ZALIEX ANTISEPTIC HAND (BENZALKONIUM CHLORIDE) SOAP [SAS HEALTHCARE INC]4Legacy NDC, 3 package rows20120913_262c135c-ac11-4a57-8c2e-85b90f5e2a0d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W74
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y4
COCAMIDOPROPYLAMINE OXIDEINACTIVE INGREDIENTM4SL82J7HK4
COCO GLUCOSIDEINACTIVE INGREDIENTICS790225B4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76452-00276452-002-00, 76452-002-01, 76452-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCO GLUCOSIDEICS790225BIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT

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
7318b746-f215-4ac9-9d0e-d2a71658134f262c135c-ac11-4a57-8c2e-85b90f5e2a0d2012-09-12WarningsExact identifier
spl id: 7318b746-f215-4ac9-9d0e-d2a71658134f
spl set id: 262c135c-ac11-4a57-8c2e-85b90f5e2a0d

Reported adverse events (FAERS/openFDA)#

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