Gel Instant Hand Sanitizer

Manufacturer
Kutol Products
Effective date
2019-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:13

Label at a glance#

ProductGel Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients / Ingrédient actif

Ethyl Alcohol 70% v/v

Alcool éthylique 70% v/v

OTC - PURPOSE SECTION

Purpose / Objectif

Antibacterial Agent

Agent antibactérien

INDICATIONS & USAGE SECTION

Uses / Utilisations: For handwashing to help reduce bacteria on the skin. Not for professional use in healthcare or food handling premises. / Pour le lavage des mains, afin de réduire les bactéries sur la peau. Ne pas utiliser à des fins professionelles dans les locaux de soins de santé ou de manipulation des aliments.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Garder hors de portée des enfants.

WARNINGS SECTION

Warnings / Avertissements :

For external use only. FLAMMABLE. Keep away from heat or flame. Avoid contact with eyes. If eye contact occurs, flush eyes with water. Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician. /

Pour usage externe seulement. INFLAMMABLE. Ne pas mettre a proximite d'un feu ou d'une flamme. Ne pas mettre dans les yeux. En cas de contact avec les yeux, rincer avec l'eau. Arrêtex l'utilisation en cas rares d'irritation ou de rougeru. Si les symptômes persistent plus de 72 heures, consultez en médecin. Garder hors de portée des enfants. En cas d'ingestion, consultez un médecin ou un centre antipoison.

DOSAGE & ADMINISTRATION SECTION

Directions / Mode d'emploi : Apply a small amount to palm. Briskly rub, covering hand with product until dry. / Verser une petite quantite dans la paume de la main. Frotter vivement les mains pour recouvrir de produit jusqu'a ce qu'elles soient seches.

INACTIVE INGREDIENT SECTION

Inactive Ingredients / Ingrédients Inactifs : water, glycerin, propylene glycol, ispropyl myristate, aloe barbadensis leaf juice, tocopheryl acetate (Vitamin E), isopropyl alcohol, carbomer, triisopropanolamine. / Eau, glycérine, propylèneglycol, myristate isopropylique, jus de feuille d'aloès barbadine, acétate tocophérylique (Vitamine E), alcool isopropylique, carbomère, triisopropanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

labellabel

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
50865-370-272021-01-29C16284748780-1ba0f9c33-0f55-a910-e053-dadaa90a0b85593ca91a-a2aa-3d1b-e053-2991aa0a0a30
50865-370-362021-01-29C16284748780-1ba0f9c33-0f55-a910-e053-dadaa90a0b85593ca91a-a2aa-3d1b-e053-2991aa0a0a30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-370-27Gel Instant Hand Sanitizer1000 mL in 1 BAGSOAP10002
50865-370-36Gel Instant Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICSOAP10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-370GEL INSTANT HAND SANITIZER (ALCOHOL) SOAP [KUTOL PRODUCTS]2Legacy NDC, 2 package rows20190117_593ca91a-a2aa-3d1b-e053-2991aa0a0a30.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
50865-37050865-370-27, 50865-370-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
7f98884b-0340-c15e-e053-2a91aa0acef0593ca91a-a2aa-3d1b-e053-2991aa0a0a302019-01-16WarningsExact identifier
spl id: 7f98884b-0340-c15e-e053-2a91aa0acef0
spl set id: 593ca91a-a2aa-3d1b-e053-2991aa0a0a30

Reported adverse events (FAERS/openFDA)#

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