FDA.reportPublic FDA data

Pure Genex Hand Sanitizer

Manufacturer
Enor International Inc. | Zhejiang Ushas Cosmetics Ltd.
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:20

Label at a glance#

ProductPure Genex Hand Sanitizer
Active ingredientALCOHOL
Label structure12 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(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 72% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

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

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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

water, glycerin, acrylates/ vinyl idsodecanoate crosspolymer, aminomethyl propanol, fragrance, panthenol, aloe barbadensis leaf juice, tocopheryl acetate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 3label 3label 2label 2labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN1
2277550ethanol 0.72 ML/ML Topical GelSCD1
2277550ethanol 72 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79654-002-012022-01-28C16284748780-1d6a99b39-df15-a426-e053-dadaa90af4c2Pure Genex Hand Sanitizer
79654-002-022022-01-28C16284748780-1d6a99b39-df15-a426-e053-dadaa90af4c2Pure Genex Hand Sanitizer
79654-002-032022-01-28C16284748780-1d6a99b39-df15-a426-e053-dadaa90af4c2Pure Genex Hand Sanitizer
79654-002-042022-01-28C16284748780-1d6a99b39-df15-a426-e053-dadaa90af4c2Pure Genex Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79654-002-01Pure Genex Hand Sanitizer100 mL in 1 BOTTLEGEL1001
79654-002-02Pure Genex Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL601
79654-002-03Pure Genex Hand Sanitizer250 mL in 1 BOTTLE, PUMPGEL2501
79654-002-04Pure Genex Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79654-002PURE GENEX HAND SANITIZER (ALCOHOL) GEL [ENOR INTERNATIONAL INC.]1Legacy NDC, 4 package rows20200811_ac881fa8-9f7b-6b2d-e053-2a95a90a127b.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79654-00279654-002-01, 79654-002-02, 79654-002-03, 79654-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
PANTHENOLWV9CM0O67ZIACT
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

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
ac881fa8-9f7a-6b2d-e053-2a95a90a127bac881fa8-9f7b-6b2d-e053-2a95a90a127b2020-08-10WarningsExact identifier
spl id: ac881fa8-9f7a-6b2d-e053-2a95a90a127b
spl set id: ac881fa8-9f7b-6b2d-e053-2a95a90a127b

Reported adverse events (FAERS/openFDA)#

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