FDA.reportPublic FDA data

HAND CLEANER HAND SANITIZER

Manufacturer
i9biz, Inc | BL Cosmetic Co., Ltd
Effective date
2020-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:38

Label at a glance#

ProductHAND CLEANER HAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Storage and handling

do not store above 105F may discolor some fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

DOSAGE & ADMINISTRATION SECTION

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Warnings

WARNINGS SECTION

For external use only: hands

Flammable, keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin

do not inhale or ingest

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

irritation and redness develop

condition persists for more than 72 hours

Directions

INDICATIONS & USAGE SECTION

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Other information

STORAGE AND HANDLING SECTION

do not store above 105F

may discolor some fabrics

harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Hyaluronate, Glycerin, 1,2-Hexanediol, Triethanolamine, Carbomer, Panthenol, Propylene Glycol, Glycyrrhiza Glabra (licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schisandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Butylene Glycol, Asiaticoside, Citrus Paradisi (Grapefruit) Fruit Extract, Pinus Sylvestris Leaf Extract, Caprylyl Glycol

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.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 74429 311 LabelNDC 74429 311 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74429-311-012021-07-23C16284748780-1c7ccaba7-25b0-fd44-e053-dadaa90aa01ba250577c-2ff4-757c-e053-2a95a90ad88b
74429-311-022021-07-23C16284748780-1c7ccaba7-25b0-fd44-e053-dadaa90aa01ba250577c-2ff4-757c-e053-2a95a90ad88b
74429-311-032021-07-23C16284748780-1c7ccaba7-25b0-fd44-e053-dadaa90aa01ba250577c-2ff4-757c-e053-2a95a90ad88b
74429-311-042021-07-23C16284748780-1c7ccaba7-25b0-fd44-e053-dadaa90aa01ba250577c-2ff4-757c-e053-2a95a90ad88b
74429-311-052021-07-23C16284748780-1c7ccaba7-25b0-fd44-e053-dadaa90aa01ba250577c-2ff4-757c-e053-2a95a90ad88b
74429-311-062021-07-23C16284748780-1c7ccaba7-25b0-fd44-e053-dadaa90aa01ba250577c-2ff4-757c-e053-2a95a90ad88b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74429-311-01HAND CLEANER HAND SANITIZER27 mL in 1 POUCHGEL271
74429-311-02HAND CLEANER HAND SANITIZER50 mL in 1 TUBEGEL501
74429-311-03HAND CLEANER HAND SANITIZER100 mL in 1 TUBEGEL1001
74429-311-04HAND CLEANER HAND SANITIZER300 mL in 1 BOTTLE, DISPENSINGGEL3001
74429-311-05HAND CLEANER HAND SANITIZER300 mL in 1 BOTTLE, PUMPGEL3001
74429-311-06HAND CLEANER HAND SANITIZER500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74429-311HAND CLEANER HAND SANITIZER (ALCOHOL) GEL [I9BIZ, INC]1Legacy NDC, 6 package rows20200410_a250577c-2ff4-757c-e053-2a95a90ad88b.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74429-31174429-311-01, 74429-311-02, 74429-311-03, 74429-311-04, 74429-311-05, 74429-311-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYALURONATE SODIUMYSE9PPT4THIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COPTIS JAPONICA ROOTJH0SWT16D1IACT
PROPOLIS WAX6Y8XYV2NOFIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PANTHENOLWV9CM0O67ZIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SCHISANDRA CHINENSIS FRUITABS794681CIACT
GINGERC5529G5JPQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ASIATICOSIDEPKO39VY215IACT
GRAPEFRUITO82C39RR8CIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT

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
a250577c-2ff5-757c-e053-2a95a90ad88ba250577c-2ff4-757c-e053-2a95a90ad88b2020-04-02WarningsExact identifier
spl id: a250577c-2ff5-757c-e053-2a95a90ad88b
spl set id: a250577c-2ff4-757c-e053-2a95a90ad88b

Reported adverse events (FAERS/openFDA)#

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