FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Jiangxi Iris Chemical Co.,Ltd
Effective date
2020-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:59

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

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 15-30°C(59-86°F) Avoid freezing andexcessive heat above40°C(104°F)

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

ethyl Alcohol 75%V/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to decrease bacteria on the skin that could cause disease. Use anywhere, anytime: car,office, hand bag, picnics,nappy change, campingt ravel

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

on children less than 2 months of age

on open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes,ears, and mouth.In case of contact with eyes,rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

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 a 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 15-30°C(59-86°F)
Avoid freezing andexcessive heat above40°C(104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water(aqua), carbomer, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

74440-031-01 Y0376-381 812 174440-031-01 Y0376-381 812 174440-031-01 470-493 0813 174440-031-01 470-493 0813 174440-031-01 Y0372-Y0375 MACYS R-0174440-031-01 Y0372-Y0375 MACYS R-0174440-031-01 470-493 0813 374440-031-01 470-493 0813 374440-031-01 470-493 0813 274440-031-01 470-493 0813 274440-031-01 Y359-366 R-0174440-031-01 Y359-366 R-0174440-031-01 470-493 0813 474440-031-01 470-493 0813 4

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
74440-031-012022-01-28C16284748780-1d6a99b39-adea-a426-e053-dadaa90af4c2031 HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74440-031-01HAND SANITIZER30 mL in 1 BOTTLEGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74440-031HAND SANITIZER GEL [JIANGXI IRIS CHEMICAL CO.,LTD]1Legacy NDC, 1 package rows20200818_ad1041ab-4e22-368c-e053-2995a90af305.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74440-03174440-031-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
ad0f91b4-5ce2-3eb0-e053-2a95a90a8fe3ad1041ab-4e22-368c-e053-2995a90af3052020-08-17WarningsExact identifier
spl id: ad0f91b4-5ce2-3eb0-e053-2a95a90a8fe3
spl set id: ad1041ab-4e22-368c-e053-2995a90af305

Reported adverse events (FAERS/openFDA)#

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