FDA.reportPublic FDA data

Hand sanitizer

Manufacturer
PurCel Labs LLC | Jiangsu Intco Medical Products Co., Ltd
Effective date
2023-08-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:56

Label at a glance#

ProductHand sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

• Put enough product in your palm to cover hands and rub hands together briskly until dry. • Children under 6 years of age should be supervised when using products.

Storage and handling

• Store below 110°F (43°C). • Avoid freezing and excessive heat above 104°F (40°C). • May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION


Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION


Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

• On children less than 2 months of age. • On open skin wounds.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

• Put enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using products.

Other information

STORAGE AND HANDLING SECTION

• Store below 110°F (43°C).

• Avoid freezing and excessive heat above 104°F (40°C).

• May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Carbomer Interpolymer (type B),Lemon oil,Glycerin,Triethanolamine, Water (Aqua).

Package label.principal display panel

2OZ2OZ2OZ2OZ4OZ4OZ4OZ4OZ16OZ16OZ16OZ16OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83584-002-022025-01-30C16284748780-12cef2736-73f3-d83d-e063-dadaa90ab31f01c826ab-464c-98e2-e063-6394a90aba20
83584-004-022025-01-30C16284748780-12cef2736-73f3-d83d-e063-dadaa90ab31f01c826ab-464c-98e2-e063-6394a90aba20
83584-116-022025-01-30C16284748780-12cef2736-73f3-d83d-e063-dadaa90ab31f01c826ab-464c-98e2-e063-6394a90aba20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83584-002-01Hand sanitizer59 mL in 1 BOTTLE, PUMPGEL593
83584-002-02Hand sanitizer200 in 1 CARTONGEL2003
83584-004-01Hand sanitizer118 mL in 1 BOTTLE, PUMPGEL1183
83584-004-02Hand sanitizer100 in 1 BOTTLE, PUMPGEL1003
83584-116-01Hand sanitizer473 mL in 1 BOTTLE, PUMPGEL4733
83584-116-02Hand sanitizer30 in 1 CARTONGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83584-002HAND SANITIZER (ALCOHOL) GEL [PURCEL LABS LLC]32 package rows20230821_01c826ab-464c-98e2-e063-6394a90aba20.zip
83584-004HAND SANITIZER (ALCOHOL) GEL [PURCEL LABS LLC]32 package rows20230821_01c826ab-464c-98e2-e063-6394a90aba20.zip
83584-116HAND SANITIZER (ALCOHOL) GEL [PURCEL LABS LLC]32 package rows20230821_01c826ab-464c-98e2-e063-6394a90aba20.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
83584-11683584-116-01, 83584-116-02
83584-00283584-002-01, 83584-002-02
83584-00483584-004-01, 83584-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEMON OILI9GRO824LLIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
ALOE VERA LEAFZY81Z83H0XIACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT
WATER059QF0KO0RIACT
LEMON OILI9GRO824LLIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
ALOE VERA LEAFZY81Z83H0XIACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT
WATER059QF0KO0RIACT
LEMON OILI9GRO824LLIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT

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
03658d11-dfb6-2944-e063-6294a90a8b8e01c826ab-464c-98e2-e063-6394a90aba202023-08-20WarningsExact identifier
spl id: 03658d11-dfb6-2944-e063-6294a90a8b8e
spl set id: 01c826ab-464c-98e2-e063-6394a90aba20

Reported adverse events (FAERS/openFDA)#

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