FDA.reportPublic FDA data

Joton Hand Sanitizer Gel

Manufacturer
L.Q JOTON JOINT STOCK COMPANY- PAINT MANUFACTURING FACTORY
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:08

Label at a glance#

ProductJoton Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredient [s]

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use [s]

INDICATIONS & USAGE SECTION

JOTON HAND SANITIZER to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • In children less than 2 months of age.
  • On open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 15-30°C (59-86°F).
  • Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, phenoxyethanol.

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:100ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77078-001-052022-01-28C16284748780-1d6a99b39-e0c9-a426-e053-dadaa90af4c2Pasion Alcohol Wet Wipes
77078-001-102022-01-28C16284748780-1d6a99b39-e0c9-a426-e053-dadaa90af4c2Pasion Alcohol Wet Wipes
77078-001-252022-01-28C16284748780-1d6a99b39-e0c9-a426-e053-dadaa90af4c2Pasion Alcohol Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77078-001-05Joton Hand Sanitizer Gel500 mL in 1 BOTTLEGEL5001
77078-001-10Joton Hand Sanitizer Gel100 mL in 1 BOTTLEGEL1001
77078-001-25Joton Hand Sanitizer Gel250 mL in 1 BOTTLEGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77078-001JOTON HAND SANITIZER GEL (ALCOHOL) GEL [L.Q JOTON JOINT STOCK COMPANY- PAINT MANUFACTURING FACTORY]1Legacy NDC, 3 package rows20200819_ad2ab0c4-18d8-f025-e053-2a95a90a2816.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77078-00177078-001-05, 77078-001-25, 77078-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALCOHOL3K9958V90MACTIB

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
ad2ab0c4-18d9-f025-e053-2a95a90a2816ad2ab0c4-18d8-f025-e053-2a95a90a28162020-08-18WarningsExact identifier
spl id: ad2ab0c4-18d9-f025-e053-2a95a90a2816
spl set id: ad2ab0c4-18d8-f025-e053-2a95a90a2816

Reported adverse events (FAERS/openFDA)#

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