FDA.reportPublic FDA data

ARTEMIS Alcohol-Free Antiseptic Foam Hand

Manufacturer
Artemis Bio-Solutions Inc
Effective date
2018-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:23

Label at a glance#

ProductARTEMIS Alcohol-Free Antiseptic Foam Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

SPL UNCLASSIFIED SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use in eyes. If contact occurs, flush eyes with water.

OTC - STOP USE SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

SPL UNCLASSIFIED SECTION

ARTEMIS BIOSOLUTIONS

Manufactured by Artemis BioSolutions.

960 N. Industrial Dr., Ste.4 Elmhurst, IL 60126.

Made in USA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRICLOSAN FREE


ARTEMIS
Many threats. One solution

ANTISEPTIC FOAM HAND SOAP

MOISTURIZES
LEAVES SKIN SOFT

Eliminates 99.999%
OF MOST COMMON GERMS THAT MAY CAUSE ILLNESS


Environmentally  Friendly
8.4  floz (250ml)

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49765-410-082021-07-23C16284748780-1c7ccaba7-1281-fd44-e053-dadaa90aa01bARTEMIS ALCOHOL-FREE Antiseptic Foam Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49765-410-08ARTEMIS Alcohol-Free Antiseptic Foam Hand250 mL in 1 BOTTLESOAP2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49765-410ARTEMIS ALCOHOL-FREE ANTISEPTIC FOAM HAND (BENZALKONIUM CHLORIDE) SOAP [ARTEMIS BIO-SOLUTIONS INC]2Legacy NDC, 1 package rows20190131_f37926ab-b5bf-4ef8-a79d-799d5500b9a4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
BEHENTRIMONIUM CHLORIDEINACTIVE INGREDIENTX7GNG3S47T1
DIHYDROXYETHYL COCAMINE OXIDEINACTIVE INGREDIENT8AR51R3BL51
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDEINACTIVE INGREDIENT0Y0NQR2GH11
GLYCERETH-2 COCOATEINACTIVE INGREDIENTJWM00VS7HC1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49765-41049765-410-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE0Y0NQR2GH1IACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
7d6516ab-ed3f-6774-e053-2991aa0aee71f37926ab-b5bf-4ef8-a79d-799d5500b9a42018-12-19WarningsExact identifier
spl id: 7d6516ab-ed3f-6774-e053-2991aa0aee71
spl set id: f37926ab-b5bf-4ef8-a79d-799d5500b9a4

Reported adverse events (FAERS/openFDA)#

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