FDA.reportPublic FDA data

ISSENGARD 24 HAND SANITIZER 3 oz

Manufacturer
Clear Lake Research, LLC | Columbia Cosmetic Manufacturing, Inc
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:07

Label at a glance#

ProductISSENGARD 24 HAND SANITIZER 3 oz
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

to help reduce germs on the skin Recommended use once a day or as needed

Dosage and administration

Apply half an inch each morning on clean skin

Label contents#

Full prescribing information#

DRUG FACTS

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride, 0.18%

PURPOSE SECTION

OTC - PURPOSE SECTION

Antimicrobial

WARNINGS

WARNINGS SECTION

For external uses only

USES

INDICATIONS & USAGE SECTION

  • to help reduce germs on the skin
  • Recommended use once a day or as needed

WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

STOP USE AND ASK A DOCTOR

OTC - STOP USE SECTION

Stop use and ask a doctor if rash, irritation, or other allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, if the product is swallowed, get medical help or contact a Poison Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply half an inch each morning on clean skin

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycine soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Tributyl Phosphate, Glycerin, t-Octylphenoxy-polyethoxyethanol, Hydroxy- ethylacrylate/Sodium Acryloyldimethyl Taurate, Copolymer, Isohexadecane, Polysorbate 60, Glyceryl Stearate, Stearic Acid, Stearyl Alcohol, Lavandula angustifolia (Lavender) Oil, Propylene Glycol, Ethyl Alcohol, Zinc Oxide CI 77947

PRINCIPAL DISPLAY PANEL - 89 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Issengard 24

Non-alcohol HAND SANITIZER

with Invisible Shield Technology

Kills > 99.99% of Germs

3 FL OZ / 89 mL

Made in USA

Product by: Clear Lake Research, LLC

www.issengard.com

Issengard 24 3 ozIssengard 24 3 oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81495-112-032023-01-30C16284748780-1e4f33bdf-a645-d8a0-e053-dadaa90a6e4ebd9c08ba-9e19-4c2e-e053-2a95a90aadd6
81495-112-032022-12-29C16284748780-1e4f33bdf-a645-d8a0-e053-dadaa90a6e4ebd9c08ba-9e19-4c2e-e053-2a95a90aadd6
81495-112-032022-07-29C16284748780-1e4f33bdf-a645-d8a0-e053-dadaa90a6e4ebd9c08ba-9e19-4c2e-e053-2a95a90aadd6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81495-112-03ISSENGARD 24 HAND SANITIZER 3 oz89 mL in 1 TUBECREAM892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81495-112ISSENGARD 24 HAND SANITIZER 3 OZ (BENZALKONIUM CHLORIDE) CREAM [CLEAR LAKE RESEARCH, LLC]2Legacy NDC, 1 package rows20211231_bd9c08ba-9e19-4c2e-e053-2a95a90aadd6.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81495-11281495-112-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
LAVENDER OILZBP1YXW0H8IACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
TRI-N-BUTYL PHOSPHATE95UAS8YAF5IACT
STEARIC ACID4ELV7Z65APIACT
ZINC OXIDESOI2LOH54ZIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
POLYSORBATE 60CAL22UVI4MIACT
SOYBEAN OIL241ATL177AIACT
OCTOXYNOL-120CAX7IO75IACT
ISOHEXADECANE918X1OUF1EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
d4631a16-1d99-bc80-e053-2995a90a242bbd9c08ba-9e19-4c2e-e053-2a95a90aadd62021-12-30WarningsExact identifier
spl id: d4631a16-1d99-bc80-e053-2995a90a242b
spl set id: bd9c08ba-9e19-4c2e-e053-2a95a90aadd6

Reported adverse events (FAERS/openFDA)#

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