FDA.reportPublic FDA data

PureUs

Manufacturer
Winmedia24
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:47

Label at a glance#

ProductPureUs Alcohol Free Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

▪ wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Alkyl-C12-C16-Dimethyl-Benzyl Chloride Dihydrate

Purpose

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

Use for hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

WARNINGS SECTION

Flammable, Keep away from fire and flames

For External use only

When using this product

▪ do not get into eyes
▪ if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

▪ irritation and redness develop

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

▪ wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Distilled water, Glycerine, Vitamin E, Lemon Essential Oil

SPL UNCLASSIFIED SECTION

0%

ALCOHOL FREE

  • Kills 99.99% of Germs
  • Antimicrobial Formula
  •  Moisturizing

DYE FREE • PHOSPHATE FREE • PARABEN FREE

Made in USA

SATISFACTION 100% GAURANTEED

Distributed by:

Winmedia24, Inc.

Studio City, CA 91604

213-713 0095

www.winmedia24.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78286-306-032022-01-28C16284748780-1d6a99b39-75f7-a426-e053-dadaa90af4c2PureUs PREMIUM HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78286-306-03PureUsAlcohol Free Hand Sanitizer1922 mL in 1 BOTTLELIQUID19221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78286-306PUREUS ALCOHOL FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [WINMEDIA24]1Legacy NDC, 1 package rows20200702_9301fe5b-5e4d-4cc8-a16e-dedf52fc7cc4.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78286-30678286-306-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
LEMON OILI9GRO824LLIACT

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
2f38b1c5-a65e-4851-b211-58d1f93fbdca9301fe5b-5e4d-4cc8-a16e-dedf52fc7cc42020-06-24WarningsExact identifier
spl id: 2f38b1c5-a65e-4851-b211-58d1f93fbdca
spl set id: 9301fe5b-5e4d-4cc8-a16e-dedf52fc7cc4

Reported adverse events (FAERS/openFDA)#

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