FDA.reportPublic FDA data

ANTIBACTERIAL HAND GEL Tootsie Roll Lemon

Manufacturer
JFL ENTERPRISES, INC | NingBo Huize Commodity Co.,Ltd.
Effective date
2018-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:46

Label at a glance#

ProductHand Sanitizer Lemon
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Rub hands thoroughly with product and allow to dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Decrease bacteria on hands

Warnings

WARNINGS SECTION

External Use Only. DO NOT EAT.

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.

WARNINGS SECTION

Flammable: Keep away from flame or high heat

Directions

DOSAGE & ADMINISTRATION SECTION

Rub hands thoroughly with product and allow to dry.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Jojoba Particles, Lemon Extract, Pigment White GB80-3040, Yellow 116C,  Propylene Glycol, Triethanolamine, Water

Stop and Ask a doctor if

OTC - STOP USE SECTION

Irritation or redness develop.

HAND SANITIZER (ALCOHOL) GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label ImageLabel Image

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
71246-4027-12020-09-27C16284748780-1ab0e2407-301a-f274-e053-dbdaa90a6471ANTIBACTERIAL HAND GEL Tootsie Roll Lemon
71246-4027-12020-09-25C16284748780-1ab0e2407-301a-f274-e053-dbdaa90a6471ANTIBACTERIAL HAND GEL Tootsie Roll Lemon
71246-4027-12020-07-22C16284748780-1ab0e2407-301a-f274-e053-dbdaa90a6471ANTIBACTERIAL HAND GEL Tootsie Roll Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71246-4027-1Hand Sanitizer Lemon40 mL in 1 POUCHGEL401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71246-4027HAND SANITIZER LEMON (ALCOHOL) GEL [JFL ENTERPRISES, INC]1Legacy NDC, 1 package rows20180301_97fb1dac-0822-440e-91c4-9f7136da513f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71246-402771246-4027-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATEN2TK31JIAHIACT
ALCOHOL3K9958V90MACTIB
JOJOBA ACIDMO7HV04S9YIACT
LEMON24RS0A988OIACT
PIGMENT YELLOW 1RMB4YA40UYIACT

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
26800236-78b3-4449-a6e7-71c0e97413d497fb1dac-0822-440e-91c4-9f7136da513f2018-01-01WarningsExact identifier
spl id: 26800236-78b3-4449-a6e7-71c0e97413d4
spl set id: 97fb1dac-0822-440e-91c4-9f7136da513f

Reported adverse events (FAERS/openFDA)#

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