FDA.reportPublic FDA data

Clean Hands Antibacterial Hand Sanitizer

Manufacturer
ENCHANTE ACCESSORIES INC. | Hangzhou Huiji Biotechnology Co., Ltd.
Effective date
2020-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:30

Label at a glance#

ProductClean Hands Antibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure6 sections

Dosage and administration

Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry Other Information Store at 20C(88" to 77"F) May discolor fabrices

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

■ Hand sanitizer to help decrease bacteria on the skin
■When water, soap & towel are not available.
■Recommended for repeated use,

WARNINGS

WARNINGS SECTION

For external use only■ Flammable
Keep away from fire or flame
Do not apply around eyes. Do not use in ears & mouth.
When using this product. avoid contact with eyes.
In case of contact flush eyes with water
Stop use and ask a doctor it redness or irritation
develop and persist for more than 72 hours

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Children must be supervised in use of this product

Directions

DOSAGE & ADMINISTRATION SECTION

Pump as needed into your palms and thoroughly
spread on both hands. Rub into skin until dry
Other Information Store at 20C(88" to 77"F)
May discolor fabrices

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50563-195-012022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-022022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-032022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-042022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-052022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-062022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-072022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-082022-01-28C16284748780-1d6a99b39-d86c-a426-e053-dadaa90af4c2d091f2ad-1e94-413a-9001-211b4e271ad9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-195-01Clean Hands Antibacterial Hand Sanitizer200 in 1 CARTONGEL2001
50563-195-01Clean Hands Antibacterial Hand Sanitizer30 mL in 1 BOTTLEGEL301
50563-195-02Clean Hands Antibacterial Hand Sanitizer150 in 1 CARTONGEL1501
50563-195-02Clean Hands Antibacterial Hand Sanitizer60 mL in 1 BOTTLEGEL601
50563-195-03Clean Hands Antibacterial Hand Sanitizer100 mL in 1 BOTTLEGEL1001
50563-195-03Clean Hands Antibacterial Hand Sanitizer100 in 1 CARTONGEL1001
50563-195-04Clean Hands Antibacterial Hand Sanitizer237 mL in 1 BOTTLEGEL2371
50563-195-04Clean Hands Antibacterial Hand Sanitizer24 in 1 CARTONGEL241
50563-195-05Clean Hands Antibacterial Hand Sanitizer20 in 1 CARTONGEL201
50563-195-05Clean Hands Antibacterial Hand Sanitizer500 mL in 1 BOTTLEGEL5001
50563-195-06Clean Hands Antibacterial Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
50563-195-06Clean Hands Antibacterial Hand Sanitizer18 in 1 CARTONGEL181
50563-195-07Clean Hands Antibacterial Hand Sanitizer3780 mL in 1 BOTTLEGEL37801
50563-195-07Clean Hands Antibacterial Hand Sanitizer4 in 1 CARTONGEL41
50563-195-08Clean Hands Antibacterial Hand Sanitizer4 in 1 CARTONGEL41
50563-195-08Clean Hands Antibacterial Hand Sanitizer5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-195CLEAN HANDS ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) GEL [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 16 package rows20200504_d091f2ad-1e94-413a-9001-211b4e271ad9.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50563-19550563-195-01, 50563-195-02, 50563-195-03, 50563-195-04, 50563-195-05, 50563-195-06, 50563-195-07, 50563-195-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 934Z135WT9208IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
a4c180a1-5bbb-071c-e053-2995a90a5638d091f2ad-1e94-413a-9001-211b4e271ad92020-05-03WarningsExact identifier
spl id: a4c180a1-5bbb-071c-e053-2995a90a5638
spl set id: d091f2ad-1e94-413a-9001-211b4e271ad9

Reported adverse events (FAERS/openFDA)#

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