FDA.reportPublic FDA data

AerisGuard Actisan Hand Sanitizer

Manufacturer
Aeris Environmental LLC | Seatex, LLC
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:25

Label at a glance#

ProductAerisGuard Actisan Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin

Dosage and administration

Apply enough product to cover hands Rub together until dry without wiping

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on the skin

WARNINGS

WARNINGS SECTION

For External use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor

  • if irritation or redness develops
  • 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

  • Apply enough product to cover hands
  • Rub together until dry without wiping

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta, phenoxyethanol, sodium benzoate, lactic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For

sensitive

skin

0% Alcohol

aeris

guard

ACTISAN

Hand Sanitizer

Complies with EN-13727-Bactericidal test

For sensitive skin Leaves soft skin feel

Contains moisturizer and emollient Mild and skin compatible

Non-tacky

Active moisturizer

Fragrance free and pH balanced

ALCOHOL

FREE

NET CONTENTS

3.5 fl. oz. (103mL)

container labelATLcontainer labelATL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN3
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD3
1049254benzalkonium chloride 0.13 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81124-001-012024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-022024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-032024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-042024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-052024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-062024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-072024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-082024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-092024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-102024-01-30C16284748780-11030e365-5102-111a-e063-dadaa90a10e2b4e1760a-fbfd-6943-e053-2a95a90ac952

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81124-001-01AerisGuard Actisan Hand Sanitizer60 mL in 1 BOTTLESOLUTION603
81124-001-02AerisGuard Actisan Hand Sanitizer103.5 mL in 1 BOTTLESOLUTION103.53
81124-001-03AerisGuard Actisan Hand Sanitizer118 mL in 1 BOTTLESOLUTION1183
81124-001-04AerisGuard Actisan Hand Sanitizer236 mL in 1 BOTTLESOLUTION2363
81124-001-05AerisGuard Actisan Hand Sanitizer473 mL in 1 BOTTLESOLUTION4733
81124-001-06AerisGuard Actisan Hand Sanitizer946 mL in 1 BOTTLESOLUTION9463
81124-001-07AerisGuard Actisan Hand Sanitizer3800 mL in 1 PAILSOLUTION38003
81124-001-08AerisGuard Actisan Hand Sanitizer19000 mL in 1 PAILSOLUTION190003
81124-001-09AerisGuard Actisan Hand Sanitizer209000 mL in 1 DRUMSOLUTION2090003
81124-001-10AerisGuard Actisan Hand Sanitizer1045000 mL in 1 TANKSOLUTION10450003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81124-001AERISGUARD ACTISAN HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [AERIS ENVIRONMENTAL LLC]3Legacy NDC, 10 package rows20221213_b4e1760a-fbfd-6943-e053-2a95a90ac952.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81124-00181124-001-01, 81124-001-02, 81124-001-03, 81124-001-04, 81124-001-05, 81124-001-06, 81124-001-07, 81124-001-08, 81124-001-09, 81124-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTIC ACID33X04XA5ATIACT
EDETATE SODIUMMP1J8420LUIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
SODIUM BENZOATEOJ245FE5EUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
efa6a572-8a60-aa1e-e053-2a95a90a5b8eb4e1760a-fbfd-6943-e053-2a95a90ac9522022-12-12WarningsExact identifier
spl id: efa6a572-8a60-aa1e-e053-2a95a90a5b8e
spl set id: b4e1760a-fbfd-6943-e053-2a95a90ac952

Reported adverse events (FAERS/openFDA)#

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