FDA.reportPublic FDA data

ELLE ANTIBACTERIAL HAND WASH

Manufacturer
Alta Sales Inc
Effective date
2020-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:44

Label at a glance#

ProductELLE ANTIBACTERIAL HAND WASH
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

• Pump into DRY hands • Lather vigorously for at least 15 seconds • Rinse and dry thoroughly

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Benzalkonium Chloride 0.24%

OTC - PURPOSE SECTION

​Purpose: Antiseptic

INDICATIONS & USAGE SECTION

Use For handwashing to decrease bacteria on the skin

WARNINGS SECTION

Warnings For external use only

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

Stop use and ask 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 into DRY hands
• Lather vigorously for at least 15 seconds
• Rinse and dry thoroughly

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Lauramine Oxide, Cetrimonium Chloride, Peg-150 Distearate, Coco Glucoside, Glyceryl Oleate, Tetrasodium Edta, Glycerin, Parfum, Citric Acid, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone.

SPL UNCLASSIFIED SECTION

Dermatologically Tested

Paraben Free

Hypoallergenic

Cruelty Free

ELLE™ is used by Alta Sales Inc under license from HACHETTE FILIPACCHI PRESSE SA, Paris, France.
Made in Turkey
www.ellepersonalcare.us

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2394451benzalkonium chloride 0.24 % Medicated Liquid SoapPSN1
2394451benzalkonium chloride 2.4 MG/ML Medicated Liquid SoapSCD1
2394451benzalkonium chloride 0.24 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79165-112-012022-01-28C16284748780-1d6a99b39-e1ea-a426-e053-dadaa90af4c2​ELLE ANTIBACTERIAL HAND WASH LAVENDER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79165-112-01ELLE ANTIBACTERIAL HAND WASH500 mL in 1 BOTTLELIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79165-112ELLE ANTIBACTERIAL HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [ALTA SALES INC]1Legacy NDC, 1 package rows20200908_b5faef98-ebbc-44a1-b6fc-b523e7aeb514.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79165-11279165-112-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERYL OLEATE4PC054V79PIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
a0fb57c0-f2b8-438c-b671-73de81dcbb8cb5faef98-ebbc-44a1-b6fc-b523e7aeb5142020-09-03WarningsExact identifier
spl id: a0fb57c0-f2b8-438c-b671-73de81dcbb8c
spl set id: b5faef98-ebbc-44a1-b6fc-b523e7aeb514

Reported adverse events (FAERS/openFDA)#

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