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 23:48:55

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin

Dosage and administration

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 106° F.(41C°)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin

WARNINGS

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

do not use in near the eyes. In case of contact, rinse eye thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts. Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

Store below 106° F.(41C°)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Triethanolamine, Carbomer, Vitamin E

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

112259ml59ml250ml250ml100ml100ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74763-001-012023-07-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-022023-07-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-032023-07-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-042023-07-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-052023-07-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-012022-03-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-022022-03-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-032022-03-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-042022-03-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-052022-03-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-012022-01-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-022022-01-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-032022-01-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-042022-01-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001
74763-001-052022-01-28C16284748780-1d6a99b39-a2f0-a426-e053-dadaa90af4c2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74763-001-01Hand Sanitizer59 mL in 1 BOTTLEGEL592
74763-001-02Hand Sanitizer100 mL in 1 BOTTLEGEL1002
74763-001-03Hand Sanitizer250 mL in 1 BOTTLEGEL2502
74763-001-04Hand Sanitizer500 mL in 1 BOTTLEGEL5002
74763-001-05Hand Sanitizer1000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74763-001HAND SANITIZER GEL [ZHEJIANG GAFLE AUTO CHEMICAL CO., LTD.]2Legacy NDC, 5 package rows20220329_a2d2e305-39ab-3c93-e053-2a95a90a80e7.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
74763-00174763-001-01, 74763-001-02, 74763-001-03, 74763-001-04, 74763-001-05

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
WATER059QF0KO0RIACT

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
db52ee85-1364-dab2-e053-2995a90a0211a2d2e305-39ab-3c93-e053-2a95a90a80e72022-03-28WarningsExact identifier
spl id: db52ee85-1364-dab2-e053-2995a90a0211
spl set id: a2d2e305-39ab-3c93-e053-2a95a90a80e7

Reported adverse events (FAERS/openFDA)#

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