FDA.reportPublic FDA data

Center for Applied Innovation LLC Hand Sanitizer

Manufacturer
GLENWAY FARMS, INC.
Effective date
2020-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:26

Label at a glance#

ProductCenter for Applied Innovation LLC Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses[s]

INDICATIONS & USAGE SECTION

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

  • 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 all surfaces. 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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

Make all things clear

Alcohol Antiseptic 80%

Topical Solution

Antiseptic Hand Rub

Non-Sterile Solution

MADE IN U.S.A

100% Recyclable PET bottle

Do Not Drink!

Help us help our Heroes and those in need.

Help us continue to provide support to those in need by a tax deductible contribution

Text HEROES2 to 71777 to learn how!

Manufactured, Packaged and Distributed By:

Glenway Farms Inc

1437 Hume Rd.

Huntly, VA 22640

Questions? Comments?

covid19@vahandsanitizer.com

www.vahandsanitizer.com

FLAMMABLE FOR EXTERNAL USE ONLY

Formulated to meet/exceed all WHO, CDC, and USP requirements

MADE IN VIRGINIA

"By Virginia Small Businesses" 

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

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
74372-002-012022-01-28C16284748780-1d6a99b39-fab3-a426-e053-dadaa90af4c2Center for Applied Innovation LLC Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74372-002-01Center for Applied Innovation LLC Hand Sanitizer500 mL in 1 BOTTLE, PLASTICSOLUTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74372-002CENTER FOR APPLIED INNOVATION LLC HAND SANITIZER (ALCOHOL) SOLUTION [GLENWAY FARMS, INC.]1Legacy NDC, 1 package rows20200822_552f0465-9d47-4929-9607-db233e1de805.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74372-00274372-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
05a060d8-3d55-4dd5-a32f-d82b77cfe80c552f0465-9d47-4929-9607-db233e1de8052020-08-20WarningsExact identifier
spl id: 05a060d8-3d55-4dd5-a32f-d82b77cfe80c
spl set id: 552f0465-9d47-4929-9607-db233e1de805

Reported adverse events (FAERS/openFDA)#

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