FDA.reportPublic FDA data

USIF 80E Hand Sanitizer

Manufacturer
US Industrial Fluids,LLC
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:54

Label at a glance#

ProductUSIF 80E 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 8 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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 fires or flames

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes, ears and mouth. In case of contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask doctor if redness or irritation develop. 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 8 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen Peroxide, Purified Water usp

PRINCIPAL DISPLAY PANEL - 12 OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

USIF 80E
HAND SANITIZER

Alcohol Antiseptic 80%
Tropical Solution
— Non-Sterile Solution —

US Industrial Fluids, LLC
460 Downs Terrace • Louisville, KY 40214
(502) 363-5600

12 OZ

PRINCIPAL DISPLAY PANEL - 12 OZ Bottle Label
PRINCIPAL DISPLAY PANEL - 12 OZ Bottle Label

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
77439-080-012022-01-28C16284748780-1d6a99b39-3dbe-a426-e053-dadaa90af4c2USIF 80E Hand Sanitizer
77439-080-022022-01-28C16284748780-1d6a99b39-3dbe-a426-e053-dadaa90af4c2USIF 80E Hand Sanitizer
77439-080-052022-01-28C16284748780-1d6a99b39-3dbe-a426-e053-dadaa90af4c2USIF 80E Hand Sanitizer
77439-080-122022-01-28C16284748780-1d6a99b39-3dbe-a426-e053-dadaa90af4c2USIF 80E Hand Sanitizer
77439-080-272022-01-28C16284748780-1d6a99b39-3dbe-a426-e053-dadaa90af4c2USIF 80E Hand Sanitizer
77439-080-552022-01-28C16284748780-1d6a99b39-3dbe-a426-e053-dadaa90af4c2USIF 80E Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77439-080-01USIF 80E Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37851
77439-080-02USIF 80E Hand Sanitizer59 mL in 1 BOTTLE, PLASTICLIQUID591
77439-080-05USIF 80E Hand Sanitizer18925 mL in 1 PAILLIQUID189251
77439-080-12USIF 80E Hand Sanitizer355 mL in 1 BOTTLE, PLASTICLIQUID3551
77439-080-27USIF 80E Hand Sanitizer1040875 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID10408751
77439-080-55USIF 80E Hand Sanitizer208175 mL in 1 DRUMLIQUID2081751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77439-080USIF 80E HAND SANITIZER (ALCOHOL) LIQUID [US INDUSTRIAL FLUIDS,LLC]1Legacy NDC, 6 package rows20200521_6c3da4bc-d8fe-4d05-b22b-eaca28b25cdc.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
77439-08077439-080-12, 77439-080-02, 77439-080-01, 77439-080-05, 77439-080-55, 77439-080-27

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
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
ef824ea9-b4d8-48a1-8917-e77dde51940d6c3da4bc-d8fe-4d05-b22b-eaca28b25cdc2020-05-19WarningsExact identifier
spl id: ef824ea9-b4d8-48a1-8917-e77dde51940d
spl set id: 6c3da4bc-d8fe-4d05-b22b-eaca28b25cdc

Reported adverse events (FAERS/openFDA)#

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