FDA.reportPublic FDA data

Foaming Hand Sanitizer

Manufacturer
Empack Spraytech Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:22

Label at a glance#

ProductFoaming Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

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

Dosage and administration

Adults and children over 2 years  For occasional and personal domestic use  Supervise children under 6 years of age when using this product to avoid swallowing  Place enough product on hands to cover all surfaces. Rub hands together for at least 30 seconds until dry.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol 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 whensoap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammability warning. Keep away from open flame and sources of heat.

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,avoid contact with eyes. If contact occurs, rinse thoroughly with water. 

OTC - STOP USE SECTION

Stop use and ask a doctor ifirritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.Topical. If swallowed, call a poison control centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 2 years 
  • For occasional and personal domestic use 
  • Supervise children under 6 years of age when using this product to avoid swallowing 
  • Place enough product on hands to cover all surfaces. Rub hands together for at least 30 seconds until dry.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Bis-PEG-12 Dimethicone, Glycerin, Aloe Barbadensis Leaf Juice

Questions?

OTC - QUESTIONS SECTION

1-866-923-2665

SPL UNCLASSIFIED SECTION

UPC

Manufactured by Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, Canada L6T 4H6

www.zytecgermbuster.ca

Made in Canada

Lot # and Expiry Date to be embossed on the bottle

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

550 ml; NDC 50021-020-01 Foaming Hand SanitizerFoaming Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616805ethanol 70 % Topical FoamPSN2
616805ethanol 0.7 ML/ML Topical FoamSCD2
616805ethanol 70 % Topical FoamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50021-020-01Foaming Hand Sanitizer550 mL in 1 BOTTLE, PUMPSOLUTION5502
50021-020-02Foaming Hand Sanitizer3785 mL in 1 BOTTLE, PUMPSOLUTION37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50021-020FOAMING HAND SANITIZER (ALCOHOL) SOLUTION [EMPACK SPRAYTECH INC.]2Current NDC, Legacy NDC, 2 package rows20241215_8bb072f2-9cd4-499d-9d7f-7166451b8f20.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50021-02050021-020-01, 50021-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
BIS-PEG-12 DIMETHICONE (500 MPA.S)2CNS542YRTIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
Foaming Hand SanitizerALCOHOLEmpack Spraytech Inc.8bb072f2-9cd4-499d-9d7f-7166451b8f202024-12-12WarningsExact identifier
ndc (package): 50021-020-01
ndc (package): 50021-020-02
ndc (product): 50021-020
ndc11 (package): 50021002002
ndc11 (package): 50021002001
spl id: 20af4f6c-4c3d-c789-e063-6294a90a0307
spl set id: 8bb072f2-9cd4-499d-9d7f-7166451b8f20

Reported adverse events (FAERS/openFDA)#

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