FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
LOTUS ARTS CRAFTS LIMITED
Effective date
2020-08-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:15

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hand Sanitizer Active ingredientHand Sanitizer Active ingredient

WARNINGS SECTION

Hand Sanitizer WarningHand Sanitizer Warning

OTC - PURPOSE SECTION

Hand Sanitizer PurposeHand Sanitizer Purpose

INDICATIONS & USAGE SECTION

Hand Sanitizer IndicationHand Sanitizer Indication

OTC - DO NOT USE SECTION

Hand Sanitizer DO NOT USEHand Sanitizer DO NOT USE

OTC - WHEN USING SECTION

Hand Sanitizer WHEN USINGHand Sanitizer WHEN USING

OTC - STOP USE SECTION

Hand Sanitizer STOP USEHand Sanitizer STOP USE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Hand Sanitizer KEEP OUTHand Sanitizer KEEP OUT

DOSAGE & ADMINISTRATION SECTION

Hand Sanitizer DOSAGEHand Sanitizer DOSAGE

STORAGE AND HANDLING SECTION

Hand Sanitizer STORAGEHand Sanitizer STORAGE

INACTIVE INGREDIENT SECTION

Hand Sanitizer INACTIVEHand Sanitizer INACTIVE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand SanitizerHand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN3
581660ethanol 0.62 ML/ML Topical GelSCD3
581660ethanol 62 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78294-002-012022-01-28C16284748780-1d6a99b39-fd4a-a426-e053-dadaa90af4c2HAND SANITIZER
78294-002-022022-01-28C16284748780-1d6a99b39-fd4a-a426-e053-dadaa90af4c2HAND SANITIZER
78294-002-032022-01-28C16284748780-1d6a99b39-fd4a-a426-e053-dadaa90af4c2HAND SANITIZER
78294-002-042022-01-28C16284748780-1d6a99b39-fd4a-a426-e053-dadaa90af4c2HAND SANITIZER
78294-002-052022-01-28C16284748780-1d6a99b39-fd4a-a426-e053-dadaa90af4c2HAND SANITIZER
78294-002-062022-01-28C16284748780-1d6a99b39-fd4a-a426-e053-dadaa90af4c2HAND SANITIZER
78294-002-072022-01-28C16284748780-1d6a99b39-fd4a-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78294-002-01Hand Sanitizer30 mL in 1 BOTTLEGEL303
78294-002-02Hand Sanitizer60 mL in 1 BOTTLEGEL603
78294-002-03Hand Sanitizer100 mL in 1 BOTTLEGEL1003
78294-002-04Hand Sanitizer250 mL in 1 BOTTLEGEL2503
78294-002-05Hand Sanitizer300 mL in 1 BOTTLEGEL3003
78294-002-06Hand Sanitizer500 mL in 1 BOTTLEGEL5003
78294-002-07Hand Sanitizer1000 mL in 1 BOTTLEGEL10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78294-002HAND SANITIZER (ALCOHOL) GEL [LOTUS ARTS CRAFTS LIMITED]3Legacy NDC, 7 package rows20201009_ad71fdcd-abb3-f0c2-e053-2a95a90ace34.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78294-00278294-002-01, 78294-002-02, 78294-002-03, 78294-002-04, 78294-002-05, 78294-002-06, 78294-002-07

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
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
ad71f040-2f8b-f1a8-e053-2a95a90a0cbfad71fdcd-abb3-f0c2-e053-2a95a90ace342020-08-22WarningsExact identifier
spl id: ad71f040-2f8b-f1a8-e053-2a95a90a0cbf
spl set id: ad71fdcd-abb3-f0c2-e053-2a95a90ace34

Reported adverse events (FAERS/openFDA)#

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