FDA.reportPublic FDA data

VASTIZER HAND SANITIZER

Manufacturer
VastMed LLC
Effective date
2022-05-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:49:31

Label at a glance#

ProductVASTIZER HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

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

Storage and handling

• Store between 1-30c (59-86c) • Avoid freezing and excessive heat above 40c (104c)

Label contents#

Full prescribing information#

Active Ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on hands that can potentially cause harm. 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

• in children less than 2 months of age

• on open skin wounds

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

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Place enough product on hands to cover the entire surface. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

• Store between 1-30c (59-86c)

• Avoid freezing and excessive heat above 40c (104c)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua), Glycerin, Propylene Glycol, Acrylates/C10-30Alkyl Acrylate  Crosspolymer, Aminomethyl Propanol, Fragrance(Parfum), Denatonium Benzoate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Maltodextrin.

SPL UNCLASSIFIED SECTION

by VastMed

75% ALCOHOL CONTENT

KILLS 99.9% OF GERMS

Waterless / Instant drying

With ALOE and Vitamin E

VastMed LLC      www.VastMed.com

Made in PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN4
1047755ethanol 0.75 ML/ML Topical SolutionSCD4
1047755ethanol 75 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79586-101-042023-07-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-162023-07-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-382023-07-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-802023-07-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-042022-05-09C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-162022-05-09C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-382022-05-09C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-802022-05-09C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-042022-01-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-162022-01-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-382022-01-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER
79586-101-802022-01-28C16284748780-1d6a99b39-f9b2-a426-e053-dadaa90af4c2VASTIZER HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79586-101-04VASTIZER HAND SANITIZER118 mL in 1 BOTTLELIQUID1184
79586-101-16VASTIZER HAND SANITIZER500 mL in 1 BOTTLELIQUID5004
79586-101-38VASTIZER HAND SANITIZER3800 mL in 1 JARLIQUID38004
79586-101-80VASTIZER HAND SANITIZER236 mL in 1 BOTTLELIQUID2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79586-101VASTIZER HAND SANITIZER (ETHYL ALCOHOL) LIQUID [VASTMED LLC]4Legacy NDC, 4 package rows20220510_18adf861-b1a5-40e5-a2bf-7e7cf132cb99.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79586-10179586-101-04, 79586-101-80, 79586-101-16, 79586-101-38

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT

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
e0d234de-0140-4ceb-a14d-2a9e75686d4a18adf861-b1a5-40e5-a2bf-7e7cf132cb992022-05-09WarningsExact identifier
spl id: e0d234de-0140-4ceb-a14d-2a9e75686d4a
spl set id: 18adf861-b1a5-40e5-a2bf-7e7cf132cb99

Reported adverse events (FAERS/openFDA)#

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