FDA.reportPublic FDA data

Mr Toms Hand Sanitizer

Manufacturer
List Distillery, LLC
Effective date
2020-06-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:17:54

Label at a glance#

ProductVYDAL Scented Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient [s] Purpose

Alcohol 80% v/v.......................................Antiseptic

OTC - DO NOT USE SECTION

Do not use

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

WARNINGS SECTION

Warnings

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. NOT FOR CONSUMPTION. DO NOT INGEST.

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Gylcerin, Hydrogen Peroxide, Orange Oil, Eucalyptus Oil, English Lavender Oil, Purified Water USP

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

INDICATIONS & USAGE SECTION

Use [s]

  • Hand sanitizer to help reduce bacteria that potentially can cause disease.
  • For use when soap and water are not available.

RECENT MAJOR CHANGES SECTION

Use [s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.

OTC - PURPOSE SECTION

Use [s]

  • Hand sanitizer helps reduce bacteria that potentially causes disease.
  • For use when soap and water are not available.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VYDAL 100 ml labelVYDAL 100 ml labelVYDAL

80% Alcohol

Scented Hand Sanitizer

Cleansing Zen

  • WHO Rocommended Hand Rub

Formulation #1

  • FOR EXTERNAL USE ONLY
  • NOT SAFE FOR CONSUMPTION
  • NON-STERILE SOLUTION

3.4 fl oz/100 mL

MADE IN USA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN6
1039339ethanol 0.8 ML/ML Topical SolutionSCD6
1039339ethanol 80 % Topical SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74563-003-012022-01-28C16284748780-1d6a99b39-a947-a426-e053-dadaa90af4c2a2621c15-1057-12cb-e053-2a95a90abab0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74563-003-01VYDAL Scented Hand Sanitizer100 mL in 1 BOTTLE, PLASTICLIQUID1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74563-003VYDAL SCENTED HAND SANITIZER LIQUID [LIST DISTILLERY, LLC]6Legacy NDC, 1 package rows20200617_a2621c15-1057-12cb-e053-2a95a90abab0.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
74563-00374563-003-01

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
ENGLISH LAVENDER OILZBP1YXW0H8IACT
ORANGE OILAKN3KSD11BIACT
EUCALYPTUS OIL2R04ONI662IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCEROL FORMAL3L7GR2604EIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
a824eb8f-b0a0-938b-e053-2995a90ac175a2621c15-1057-12cb-e053-2a95a90abab02020-06-15WarningsExact identifier
spl id: a824eb8f-b0a0-938b-e053-2995a90ac175
spl set id: a2621c15-1057-12cb-e053-2a95a90abab0

Reported adverse events (FAERS/openFDA)#

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