FDA.reportPublic FDA data

Pure label advanced hand sanitizer ge l plus

Manufacturer
NATURE REPUBLIC CO., LTD. | EVERCOS CO. LTD.
Effective date
2020-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:03

Label at a glance#

ProductPure label advanced hand sanitizer ge l plus
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Uses: Hand sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and administration

Directions: • 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: ALCOHOL 70%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water, Carbomer, Triethanolamine, Isopropyl myristate, Fragrance, Rosemary Extract, Green Tea Extract, Aloe Extract, Hexyl Cinnamal, Linalool, Limonene

PURPOSE

OTC - PURPOSE SECTION

Purpose: ANTISEPTIC

WARNINGS

WARNINGS SECTION

WARNINGS:

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.

KEEP OUT OF REACH OF CHILDREN

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.

Uses

INDICATIONS & USAGE SECTION

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

• 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

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-531-012022-01-28C16284748780-1d6a99b39-8a3e-a426-e053-dadaa90af4c232753d9b-ca2e-423e-90e9-3f264c190ad4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51346-531-01Pure label advanced hand sanitizer ge l plus500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51346-531PURE LABEL ADVANCED HAND SANITIZER GE L PLUS (ALCOHOL) GEL [NATURE REPUBLIC CO., LTD.]1Legacy NDC, 1 package rows20200427_32753d9b-ca2e-423e-90e9-3f264c190ad4.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-53151346-531-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
Isopropyl myristate0RE8K4LNJSIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOEV5VD430YW9IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT

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
1606fc81-9d6e-4a53-83b2-fc5c3e7f14f932753d9b-ca2e-423e-90e9-3f264c190ad42020-04-26WarningsExact identifier
spl id: 1606fc81-9d6e-4a53-83b2-fc5c3e7f14f9
spl set id: 32753d9b-ca2e-423e-90e9-3f264c190ad4

Reported adverse events (FAERS/openFDA)#

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