FDA.reportPublic FDA data

ARTEMIS Alcohol-Free Antiseptic Foam Hand Sanitizer

Manufacturer
Artemis Bio-Solutions, Inc.
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:21:00

Label at a glance#

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

Indications and uses

For hand sanitizing 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 hand sanitizing 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.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Rub hands together briskly until dry.

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

Updated LabelUpdated Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49765-310-012021-07-23C16284748780-1c7ccaba7-23a3-fd44-e053-dadaa90aa01bARTEMIS ALCOHOL-FREE Antiseptic Foam Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49765-310-01ARTEMIS Alcohol-Free Antiseptic Foam Hand Sanitizer50 mL in 1 BOTTLELIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49765-310ARTEMIS ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ARTEMIS BIO-SOLUTIONS, INC.]4Legacy NDC, 1 package rows20200711_be8ab2b6-5581-4792-8fcd-bbbf98b52c5c.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
49765-31049765-310-01

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 · Source PDF

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
aa185f08-6b25-6aaa-e053-2a95a90a2db1be8ab2b6-5581-4792-8fcd-bbbf98b52c5c2020-07-10WarningsExact identifier
spl id: aa185f08-6b25-6aaa-e053-2a95a90a2db1
spl set id: be8ab2b6-5581-4792-8fcd-bbbf98b52c5c

Reported adverse events (FAERS/openFDA)#

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