New Clean Hand Sanitizer

Manufacturer
U2 | HEALKINBIO CO.
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:52

Label at a glance#

ProductNew Clean Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

■ instant hand antiseptic to decrease bacteria on the skin ■ recommended for repeated use

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ALCOHOL 62% v/v

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water, Triethanolamine, Polysorbate 20, Glycerin, Carbomer, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Fragrance

PURPOSE

OTC - PURPOSE SECTION

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

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

■ instant hand antiseptic to decrease bacteria on the skin
■ recommended for repeated use

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

OTHER SAFETY INFORMATION

■ Store between 1~30℃
■ Avoid freezing and excessive heat above 40℃ (104F)

Questions?

OTC - QUESTIONS SECTION

■ +82-10-2863-2511 (Mon. to Fri. 10 AM-5 PM)

PACKAGE LABEL : New Clean Hand Sanitizer 60mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

PACKAGE LABEL : New Clean Hand Sanitizer 500mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809603782090GTIN-13: 8809603782090
EAN-13: 8809603782090
GTIN storage (14 digits): 08809603782090
500 bottle.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78023-010-012022-01-28C16284748780-1d6a99b39-c048-a426-e053-dadaa90af4c2f9ffcc60-aa6b-43d6-9131-b23d88b3fd40
78023-010-022022-01-28C16284748780-1d6a99b39-c048-a426-e053-dadaa90af4c2f9ffcc60-aa6b-43d6-9131-b23d88b3fd40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78023-010-01New Clean Hand Sanitizer60 mL in 1 BOTTLE, PUMPGEL601
78023-010-02New Clean Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78023-010NEW CLEAN HAND SANITIZER (ALCOHOL) GEL [U2]1Legacy NDC, 2 package rows20200520_f9ffcc60-aa6b-43d6-9131-b23d88b3fd40.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
78023-01078023-010-01, 78023-010-02

Ingredients#

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

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

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
f3996a7d-000c-4630-847b-99d598a7425af9ffcc60-aa6b-43d6-9131-b23d88b3fd402020-05-20WarningsExact identifier
spl id: f3996a7d-000c-4630-847b-99d598a7425a
spl set id: f9ffcc60-aa6b-43d6-9131-b23d88b3fd40

Reported adverse events (FAERS/openFDA)#

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