FDA.reportPublic FDA data

ISSENGARD 24 HAND SANITIZER 3 oz

Manufacturer
CLEAR LAKE RESEARCH, LLC
Effective date
2022-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:52:46

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#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

Benzalkonium Chloride 0.18%

Purpose section

OTC - PURPOSE SECTION

Antimicrobial

Warnings

WARNINGS SECTION

For external uses only

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

When using this product

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

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.

Uses

INDICATIONS & USAGE SECTION

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

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 - 30 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISSENGARD

Hand Cream Protectant

Kills > 99.99% of Germs

Non-alcohol HAND SANITIZER

1 FL OZ / 30 mL

Made in USA

Issengard 1 oz front labelIssengard 1 oz front label

Issengard 1 oz back labelIssengard 1 oz back label

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
81495-112-012024-01-30C16284748780-1e4f33bdf-a413-d8a0-e053-dadaa90a6e4ed4bb96cb-c448-7193-e053-2995a90ad5d6
81495-112-012022-12-29C16284748780-1e4f33bdf-a413-d8a0-e053-dadaa90a6e4ed4bb96cb-c448-7193-e053-2995a90ad5d6
81495-112-012022-07-29C16284748780-1e4f33bdf-a413-d8a0-e053-dadaa90a6e4ed4bb96cb-c448-7193-e053-2995a90ad5d6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81495-112-01ISSENGARD 24 HAND SANITIZER 3 oz30 mL in 1 TUBECREAM302

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 rows20221230_d4bb96cb-c448-7193-e053-2995a90ad5d6.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81495-11281495-112-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 60CAL22UVI4MIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
ISOHEXADECANE918X1OUF1EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ZINC OXIDESOI2LOH54ZIACT
GLYCERINPDC6A3C0OXIACT
OCTOXYNOL-120CAX7IO75IACT
ALCOHOL3K9958V90MIACT
SOYBEAN OIL241ATL177AIACT
LAVENDER OILZBP1YXW0H8IACT
SUNFLOWER OIL3W1JG795YIIACT
TRI-N-BUTYL PHOSPHATE95UAS8YAF5IACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
STEARIC ACID4ELV7Z65APIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
f0ff1932-36af-200e-e053-2a95a90a6895d4bb96cb-c448-7193-e053-2995a90ad5d62022-12-29WarningsExact identifier
spl id: f0ff1932-36af-200e-e053-2a95a90a6895
spl set id: d4bb96cb-c448-7193-e053-2995a90ad5d6

Reported adverse events (FAERS/openFDA)#

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