FDA.reportPublic FDA data

Extra Stength Hand Sanitizer

Manufacturer
Empack Spraytech Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:36

Label at a glance#

ProductExtra Stength Hand Sanitizer Zytec Germ Buster
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduces bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available

Dosage and administration

Hold can at 10 inches distance Spray enough product on hands to cover all surfaces. Rub hands together until dry Supervise children under 6 years of age when using this product to avoid swallowing

Label contents#

Full prescribing information#

Active Ingredients (w/w )

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduces bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and

water are not available

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • in children less than 2 months age
  • on open skin wounds

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs.

OTC - WHEN USING SECTION

When using this productkeep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water

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

  • Hold can at 10 inches distance
  • Spray enough product on hands to cover all surfaces. Rub hands together until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature 15-30 C (59-86°F). May stain surfaces and fabrics.
  • Avoid freezing and extrensive heat avbove 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isobutane, Fragrance (Parfum).

Questions ?

OTC - QUESTIONS SECTION

1-866-923-2665

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

UPC Please recycle (+ logo) Lot # and Expiry Date to be embossed on the tube seal

Principal Display Panel -

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Stength Hand Sanitizer Spray

Alcohol Antiseptic 80%

Packge size ranges between 51g (100 ml) to 252g (500 ml)

Principal Display Panel - Extra Stength Hand SanitizerPrincipal Display Panel - Extra Stength Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN6
1241663ethanol 0.8 ML/ML Topical SpraySCD6
1241663ethanol 80 % Topical SpraySY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50021-008-01Extra Stength Hand SanitizerZytec Germ Buster51 g in 1 CANAEROSOL, SPRAY516
50021-008-02Extra Stength Hand SanitizerZytec Germ Buster100 g in 1 CANAEROSOL, SPRAY1006
50021-008-03Extra Stength Hand SanitizerZytec Germ Buster125 g in 1 CANAEROSOL, SPRAY1256
50021-008-04Extra Stength Hand SanitizerZytec Germ Buster200 g in 1 CANAEROSOL, SPRAY2006
50021-008-05Extra Stength Hand SanitizerZytec Germ Buster253 g in 1 CANAEROSOL, SPRAY2536
50021-008-06Extra Stength Hand SanitizerZytec Germ Buster400 g in 1 CANAEROSOL, SPRAY4006
50021-008-07Extra Stength Hand SanitizerZytec Germ Buster70 g in 1 CANAEROSOL, SPRAY706
50021-008-08Extra Stength Hand SanitizerZytec Germ Buster352 g in 1 CANAEROSOL, SPRAY3526
50021-008-09Extra Stength Hand SanitizerZytec Germ Buster176 g in 1 CANAEROSOL, SPRAY1766

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50021-008EXTRA STENGTH HAND SANITIZER ZYTEC GERM BUSTER (ALCOHOL 80%W/W) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]6Current NDC, Legacy NDC, 9 package rows20241215_da854195-3a50-4fae-a5ea-183bf524c973.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
50021-00850021-008-01, 50021-008-02, 50021-008-03, 50021-008-04, 50021-008-05, 50021-008-06, 50021-008-07, 50021-008-08, 50021-008-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIME (CITRUS)8CZS546954IACT
ISOBUTANEBXR49TP611IACT
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
Extra Stength Hand Sanitizer Zytec Germ BusterALCOHOL 80%W/WEmpack Spraytech Inc.da854195-3a50-4fae-a5ea-183bf524c9732024-12-12WarningsExact identifier
ndc (package): 50021-008-07
ndc (package): 50021-008-03
ndc (package): 50021-008-06
ndc (package): 50021-008-04
ndc (package): 50021-008-01
ndc (package): 50021-008-09
ndc (package): 50021-008-02
ndc (package): 50021-008-05
ndc (package): 50021-008-08
ndc (product): 50021-008
ndc11 (package): 50021000801
ndc11 (package): 50021000806
ndc11 (package): 50021000808
ndc11 (package): 50021000805
ndc11 (package): 50021000809
ndc11 (package): 50021000803
ndc11 (package): 50021000804
ndc11 (package): 50021000807
ndc11 (package): 50021000802
spl id: 20af5ae7-2a91-ff8d-e063-6394a90ad503
spl set id: da854195-3a50-4fae-a5ea-183bf524c973

Reported adverse events (FAERS/openFDA)#

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