FDA.reportPublic FDA data

70% Alcohol Hand Sanitizer Gel

Manufacturer
Kutol Products Company, Inc.
Effective date
2018-02-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:52

Label at a glance#

Product70% Alcohol Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v.....Antibacterial Agent

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Triisopropanolamine

OTC - PURPOSE SECTION

For handwashing to help reduce bacteria on the skin

WARNINGS SECTION

For external use only.

Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION SECTION

Apply to hair or body. Work into a rich lather. Massage hair and body completely for at least 30 seconds. Rinse thoroughly. Dry completely.

INDICATIONS & USAGE SECTION

For handwashing to help reduce bacteria on the skin.

Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098175ethanol 70 % Medicated Liquid SoapPSN2
1098175ethanol 0.7 ML/ML Medicated Liquid SoapSCD2
1098175ethanol 70 % Medicated Liquid SoapSY2
1098175ethyl alcohol 70 % Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50865-074-412021-01-29C16284748780-1ba0f9c33-4bf5-a910-e053-dadaa90a0b8570% Alcohol Hand Sanitizer Gel
50865-074-442021-01-29C16284748780-1ba0f9c33-4bf5-a910-e053-dadaa90a0b8570% Alcohol Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-074-4170% Alcohol Hand Sanitizer1000 mL in 1 BAGSOAP10002
50865-074-4170% Alcohol Hand Sanitizer6 in 1 PACKETSOAP62
50865-074-4470% Alcohol Hand Sanitizer4 in 1 PACKETSOAP42
50865-074-4470% Alcohol Hand Sanitizer1000 mL in 1 BAGSOAP10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-07470% ALCOHOL HAND SANITIZER (ALCOHOL) SOAP [KUTOL PRODUCTS COMPANY, INC.]2Legacy NDC, 4 package rows20180308_6648af79-8256-328a-e053-2a91aa0a9157.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50865-07450865-074-41, 50865-074-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT

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
66afb1d0-0726-7c1a-e053-2a91aa0aadad6648af79-8256-328a-e053-2a91aa0a91572018-02-26WarningsExact identifier
spl id: 66afb1d0-0726-7c1a-e053-2a91aa0aadad
spl set id: 6648af79-8256-328a-e053-2a91aa0a9157

Reported adverse events (FAERS/openFDA)#

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