FDA.reportPublic FDA data

not have

Manufacturer
ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD
Effective date
2022-03-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:48:56

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

For hand sanitizing to decrease bacteria on skin,FOR EXTERNAL USE ONLY.KEEP OUT OF EYES.IF EYE CONTACT OCCLRED FLUSH IMMEDIATELY WITH WATER AND CALL A DOCOTR .STOP USE AND ASK A DOCTOR IF IRRITATION DEVELOPS.

Dosage and administration

Apply a pea sized amount onto your hand, and rub thoroughly until dry,Use as needed,For children under 6,use with adult supervision.

Storage and handling

Store below 106°F.(41°C)

Label contents#

Full prescribing information#

ACTIVE INGERDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%.

PURPOSE

OTC - PURPOSE SECTION

Antimicrobial

USES

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on skin,FOR EXTERNAL USE ONLY.KEEP OUT OF EYES.IF EYE CONTACT OCCLRED FLUSH IMMEDIATELY WITH WATER AND CALL A DOCOTR .STOP USE AND ASK A DOCTOR IF IRRITATION DEVELOPS.

WARNINGS

WARNINGS SECTION

FLAMABLE.KEEP AWAY FIRE OR FLAME.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

CALL A DOCTOR OR POISON CENTER IF SWALLOWED.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply a pea sized amount onto your hand, and rub thoroughly until dry,Use as needed,For children under 6,use with adult supervision.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store below 106°F.(41°C)

INACTIVE INGERDIENTS

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ml label60 ml label100 ml label100 ml label250 ml label250 ml label500 ml label500 ml label1000 ml label1000 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN4
1305100ethanol 0.75 ML/ML Topical GelSCD4
1305100ethanol 75 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74763-012-012023-07-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-022023-07-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-032023-07-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-042023-07-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-052023-07-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-012022-03-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-022022-03-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-032022-03-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-042022-03-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-052022-03-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-012022-01-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-022022-01-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-032022-01-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-042022-01-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER
74763-012-052022-01-28C16284748780-1d6a99b39-e0a8-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74763-012-01HAND SANITIZER60 mL in 1 BOTTLEGEL604
74763-012-02HAND SANITIZER100 mL in 1 BOTTLEGEL1004
74763-012-03HAND SANITIZER250 mL in 1 BOTTLEGEL2504
74763-012-04HAND SANITIZER500 mL in 1 BOTTLEGEL5004
74763-012-05HAND SANITIZER1000 mL in 1 BOTTLEGEL10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74763-012HAND SANITIZER GEL [ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD]4Legacy NDC, 5 package rows20220329_a47e332f-2961-137b-e053-2a95a90a07f7.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
74763-01274763-012-01, 74763-012-02, 74763-012-03, 74763-012-04, 74763-012-05

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

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
db52ee85-1361-dab2-e053-2995a90a0211a47e332f-2961-137b-e053-2a95a90a07f72022-03-28WarningsExact identifier
spl id: db52ee85-1361-dab2-e053-2995a90a0211
spl set id: a47e332f-2961-137b-e053-2a95a90a07f7

Reported adverse events (FAERS/openFDA)#

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