FDA.reportPublic FDA data

Hand Sanitizer 500ml

Manufacturer
E.CIS Cosmetic Co.,Ltd
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:16:51

Label at a glance#

ProductHand Sanitizer 500ml
Active ingredientALCOHOL
Label structure13 sections

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.

Storage and handling

Other Information. Storage and Handling-Store between 15-30C (59-86F), ▪ Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v..........................Antiseptic ACTIVEACTIVE

Purpose

OTC - PURPOSE SECTION

Purpose.Antiseptic

PURPOSEPURPOSE

Use[s]

INDICATIONS & USAGE SECTION

Use[s]-Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Use[s]Use[s]

Warnings

WARNINGS SECTION

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

WarningsWarnings

Do not use

OTC - DO NOT USE SECTION

Do not use-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 using this productWhen using this product

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 use and ask a doctorStop use and ask a doctor

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 out of reach of childrenKeep out of reach of children

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.

DirectionsDirections

Other Information

STORAGE AND HANDLING SECTION

Other Information. Storage and Handling-Store between 15-30C (59-86F), ▪ Avoid freezing and excessive heat above 40C (104F)

Other InformationOther Information

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients-Water, Glycerin, Carbomer, Aminomethyl Propanol, Mentha Arvensis Leaf Oil, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract

Inactive ingredientsInactive ingredients

Questions or Comments

OTC - QUESTIONS SECTION

Questions or Comments 1-800-819-4159

Questions or CommentsQuestions or Comments

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EPU INSTANT HAND SANITIZER NON-STERILE SOLUTION Help Reduce Bacteria On The Skin.
For all day use, No Sticky, Deep Moisturizing, 500 mL (16.9 fl. oz.)

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73862-202-112025-06-18C16284748780-1d6a99b39-ae76-a426-e053-dadaa90af4c2EPU Hand Sanitizer 500ml
73862-202-112022-01-28C16284748780-1d6a99b39-ae76-a426-e053-dadaa90af4c2EPU Hand Sanitizer 500ml

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73862-202HAND SANITIZER 500ML (ETHYLE ALCOHOL) GEL [E.CIS COSMETIC CO.,LTD]6Legacy NDC20200828_a231b1f3-d26b-22dc-e053-2995a90a9135.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73862-20273862-202-10, 73862-202-11

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
CARBOMER 9404Q93RCW27EIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT

Source Document#

Source XML · Source PDF

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
37d32757-43e0-2d8c-e063-6294a90a4cbca231b1f3-d26b-22dc-e053-2995a90a91352025-06-18WarningsExact identifier
spl set id: a231b1f3-d26b-22dc-e053-2995a90a9135

Reported adverse events (FAERS/openFDA)#

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