FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD
Effective date
2022-03-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:56

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 59°-86°F(15°-30°C) Avoid treezing and excessive heat above 104°F(40 °C)

Label contents#

Full prescribing information#

ACTIVE INGERDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%.

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USES

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

WARNINGS SECTION

For external use only.
Flammable. Keep away from heat or flame. Keep out of reach of children.
If swallowed, get medical help or contact
Poison Control Center right away.

OTC - DO NOT USE SECTION

on open skin wounds.
on children under the age of 2 months.

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.

OTC - STOP USE SECTION

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
Poison Control Center right away.

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

STORAGE AND HANDLING SECTION

store between 59°-86°F(15°-30°C)
Avoid treezing and excessive heat above 104°F(40 °C)

INACTIVE INGERDIENTS

INACTIVE INGREDIENT SECTION

Purified Water,Glycerin,Triethanolamine,Carbomer,Vitamin E.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

47347323623660ml60ml6060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74763-003-012023-07-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-022023-07-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-032023-07-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-012022-03-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-022022-03-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-032022-03-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-012022-01-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-022022-01-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER
74763-003-032022-01-28C16284748780-1d6a99b39-daef-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74763-003-01HAND SANITIZER60 mL in 1 BOTTLEGEL602
74763-003-02HAND SANITIZER236 mL in 1 BOTTLEGEL2362
74763-003-03HAND SANITIZER473 mL in 1 BOTTLEGEL4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74763-003HAND SANITIZER GEL [ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD]2Legacy NDC, 3 package rows20220329_a72b946a-9d68-b62d-e053-2995a90a87a1.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74763-00374763-003-01, 74763-003-02, 74763-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
db52ee85-1363-dab2-e053-2995a90a0211a72b946a-9d68-b62d-e053-2995a90a87a12022-03-28WarningsExact identifier
spl id: db52ee85-1363-dab2-e053-2995a90a0211
spl set id: a72b946a-9d68-b62d-e053-2995a90a87a1

Reported adverse events (FAERS/openFDA)#

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