FDA.reportPublic FDA data

FIRST HAND SANITIZER ETHANOL GEL 500ml

Manufacturer
THE NATURAL COSMETIC CO., LTD
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:38

Label at a glance#

ProductFIRST HAND SANITIZER
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children 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

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 fire and flame. WarningWarning

Do not use

OTC - DO NOT USE SECTION

in children less than 2 month of age

on open skin wounds Do not useDo not use

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water. When using this productWhen using this product

Stop use and ask a doctor

OTC - STOP USE SECTION

If irritation or rash occurs, These may be signs of 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

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

Place enough product on hands to cover all surfaces.

Rub hands together until dry.

Supervise children when using this product to avoid swallowing. DirectionsDirections

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, Glycerin, Carbomer, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Artemisia Princeps Extract, Menthol, Triethanolamine

Inactive ingredientsInactive ingredients

Questions or Comments?

OTC - QUESTIONS SECTION

800-226-9047

Questions or Comments?Questions or Comments?

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRST

HAND SANITIZER

Hand Sanitizer Gel

With Aloe & Green tea extract

No Paraben / Fragrance-free

Moisturizing & Refreshing

Effectively reduces bacteria

without over drying the hands Package LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76764-7777-22021-07-23C16284748780-1c7ccaba7-187e-fd44-e053-dadaa90aa01bFIRST HAND SANITIZER ETHANOL GEL 500ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76764-7777-1FIRST HAND SANITIZER500 mL in 1 BOTTLEGEL5001
76764-7777-2FIRST HAND SANITIZER20 in 1 CARTONGEL201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76764-7777FIRST HAND SANITIZER (ETHYL ALCOHOL) GEL [THE NATURAL COSMETIC CO., LTD]1Legacy NDC, 2 package rows20200709_a8f37c66-0b4d-4f7c-e053-2995a90a4dea.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
76764-777776764-7777-1, 76764-7777-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ARTEMISIA PRINCEPS LEAFSY077EW02GIACT

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
a8f37c66-0b4e-4f7c-e053-2995a90a4deaa8f37c66-0b4d-4f7c-e053-2995a90a4dea2020-06-25WarningsExact identifier
spl id: a8f37c66-0b4e-4f7c-e053-2995a90a4dea
spl set id: a8f37c66-0b4d-4f7c-e053-2995a90a4dea

Reported adverse events (FAERS/openFDA)#

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