Hand Sanitizer FOAM

Manufacturer
PurCel Labs LLC | Zhongshan Dermey Commodity Co.,Ltd
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:09:24

Label at a glance#

ProductHand Sanitizer FOAM
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 until dry. • Children under 6 years of age should be supervised when using this product.

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

OTC - ACTIVE INGREDIENT SECTION


Ethyl 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 - ASK DOCTOR 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 until dry.
• Children under 6 years of age should be supervised when using this product.

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


Water, Peg-10 Dimethicone, Aloe Barbadensis Extract, Glycerin, Propylene Glycol, Peg-7 Glyceryl Cocoate,
Tocopheryl Acetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83584-225-0183584-225-0183584-225-0283584-225-0283584-225-0383584-225-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616805ethanol 70 % Topical FoamPSN5
616805ethanol 0.7 ML/ML Topical FoamSCD5
616805ethanol 70 % Topical FoamSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83584-225-032025-07-29C16284748780-13b156c62-2fb3-fb37-e063-e6dba90a4e070e1f48d4-4cdc-7ebf-e063-6394a90a108b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83584-225-01Hand Sanitizer FOAM1400 mL in 1 BOTTLEAEROSOL, FOAM14005
83584-225-02Hand Sanitizer FOAM2 in 1 BOXAEROSOL, FOAM25
83584-225-03Hand Sanitizer FOAM6 in 1 CARTONAEROSOL, FOAM65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83584-225HAND SANITIZER FOAM (ETHANOL ALCOHOL) AEROSOL, FOAM [PURCEL LABS LLC]53 package rows20240307_0e1f48d4-4cdc-7ebf-e063-6394a90a108b.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
83584-22583584-225-01, 83584-225-02, 83584-225-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
12eb53ff-a512-a834-e063-6294a90a88ba0e1f48d4-4cdc-7ebf-e063-6394a90a108b2024-03-05WarningsExact identifier
spl id: 12eb53ff-a512-a834-e063-6294a90a88ba
spl set id: 0e1f48d4-4cdc-7ebf-e063-6394a90a108b

Reported adverse events (FAERS/openFDA)#

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