FDA.reportPublic FDA data

K-pure Hand Sanitizer 70% 500ml

Manufacturer
Metapola Aroma Co., Ltd. | Metapola Aroma Co., Ltd
Effective date
2020-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:15

Label at a glance#

ProductK-pure Hand Sanitizer 70% 500ml
Active ingredientALCOHOL
Label structure13 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

Ethyl Alcohol 70% v/v

Active IngredientActive Ingredient

Purpose

OTC - PURPOSE SECTION

Antiseptic

PurposePurpose

Use

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

useuse

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

WarningWarning

Do not use

OTC - DO NOT USE SECTION

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

Do not useDo not use

When using this product

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.

When usingWhen using

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop useStop use

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.

Keep outKeep out

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.

DirectionDirection

Other information

STORAGE AND HANDLING SECTION

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

Other informationOther information

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Methyl Gluceth-20, PEG-60 Hydrogenated Castor Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Hyaluronic Acid, Aminomethyl Propanol, Fragrance

Inactive ingredientsInactive ingredients

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-461-5824

QuestionQuestion

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

K-Pure

HAND

SANITIZER

70% Alcohol

MOISTURIZING FORMULA

VITAMIN E

ALOE VERA

16.9 fl.oz (500ml)

PDPPDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809168480011GTIN-13: 8809168480011
EAN-13: 8809168480011
GTIN storage (14 digits): 08809168480011		KPure Hand Sanitizer 500ml 070920.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77680-100-012022-01-28C16284748780-1d6a99b39-cf8b-a426-e053-dadaa90af4c2Kpure Hand Sanitizer 70% 500ml

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77680-100K-PURE HAND SANITIZER 70% 500ML (ETHYL ALCOHOL) GEL [METAPOLA AROMA CO., LTD.]1Legacy NDC20200714_aa603d8f-c3b0-51ba-e053-2995a90ab834.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77680-10077680-100-01

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
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
HYALURONIC ACIDS270N0TRQYIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
METHYL GLUCETH-20J3QD0LD11PIACT

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
418eca41-9eae-1fca-e063-6394a90aaa16aa603d8f-c3b0-51ba-e053-2995a90ab8342025-10-19WarningsExact identifier
spl set id: aa603d8f-c3b0-51ba-e053-2995a90ab834

Reported adverse events (FAERS/openFDA)#

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