FDA.reportPublic FDA data

Klean GeniX Hand Sanitizer

Manufacturer
Custom Chemical Services, LLC
Effective date
2021-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:38

Label at a glance#

ProductKlean GeniX Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other Information Store under 105°F. 

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

WARNINGS SECTION

Warning Flammable. Keep away from fire or flame. For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING SECTION

Other Information Store under 105°F. 

DOSAGE & ADMINISTRATION SECTION

Directions Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Purified water, Glycerin USP, Carbomer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78174-052-102023-01-30C16284748780-1f386c649-bff1-0266-e053-dadaa90a7c1a9f78e110-7e3c-4210-bfbe-bf62a8d441c2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78174-052-10Klean GeniX Hand Sanitizer0.004 L in 1 POUCHGEL0.0041

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78174-052KLEAN GENIX HAND SANITIZER (ALCOHOL) GEL [CUSTOM CHEMICAL SERVICES, LLC]1Legacy NDC, 1 package rows20210413_9f78e110-7e3c-4210-bfbe-bf62a8d441c2.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78174-05278174-052-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
water059QF0KO0RIACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)F01RIY4371IACT

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
39f23de6-5aab-415b-9524-2cc2ca05054d9f78e110-7e3c-4210-bfbe-bf62a8d441c22021-04-12WarningsExact identifier
spl id: 39f23de6-5aab-415b-9524-2cc2ca05054d
spl set id: 9f78e110-7e3c-4210-bfbe-bf62a8d441c2

Reported adverse events (FAERS/openFDA)#

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