FDA.reportPublic FDA data

Pure USA Hand Sanitizer

Manufacturer
Pure USA, LLC
Effective date
2020-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:04

Label at a glance#

ProductPure USA Hand Sanitizer
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.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings For external use only. Flammable. Keep away from flame 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 INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP, fragrance

SPL UNCLASSIFIED SECTION

Manufactured By:

Pure USA, LLC

Richand Hills, TX 76118

MADE IN USA

833-4-MY-PURE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackagingPackagingPackaging

PackagingPackaging

PackagingPackaging

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
80665-101-012022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER
80665-101-032022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER
80665-101-052022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER
80665-101-102022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER
80665-101-152022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER
80665-101-182022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER
80665-101-552022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER
80665-101-752022-01-28C16284748780-1d6a99b39-483b-a426-e053-dadaa90af4c2PURE USA The Original HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80665-101-01Pure USA Hand Sanitizer3.78 L in 1 JUGLIQUID3.781
80665-101-03Pure USA Hand Sanitizer3 L in 1 POUCHLIQUID31
80665-101-05Pure USA Hand Sanitizer1 in 1 BOXLIQUID11
80665-101-05Pure USA Hand Sanitizer5 L in 1 POUCHLIQUID51
80665-101-10Pure USA Hand Sanitizer1 in 1 BOXLIQUID11
80665-101-10Pure USA Hand Sanitizer10 L in 1 POUCHLIQUID101
80665-101-15Pure USA Hand Sanitizer1.5 L in 1 POUCHLIQUID1.51
80665-101-18Pure USA Hand Sanitizer18 L in 1 POUCHLIQUID181
80665-101-18Pure USA Hand Sanitizer1 in 1 BOXLIQUID11
80665-101-55Pure USA Hand Sanitizer208.2 L in 1 DRUMLIQUID208.21
80665-101-75Pure USA Hand Sanitizer0.75 L in 1 POUCHLIQUID0.751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80665-101PURE USA HAND SANITIZER (ETHYL ALCOHOL) LIQUID [PURE USA, LLC]1Legacy NDC, 11 package rows20201007_1f935afc-6a99-480a-ae5f-e0a9c71b9842.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80665-10180665-101-75, 80665-101-15, 80665-101-03, 80665-101-01, 80665-101-05, 80665-101-10, 80665-101-18, 80665-101-55

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
89f3c496-5608-4b08-8c8f-ff1e4b169ad41f935afc-6a99-480a-ae5f-e0a9c71b98422020-09-28WarningsExact identifier
spl id: 89f3c496-5608-4b08-8c8f-ff1e4b169ad4
spl set id: 1f935afc-6a99-480a-ae5f-e0a9c71b9842

Reported adverse events (FAERS/openFDA)#

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