FDA.reportPublic FDA data

Foam Hand Sanitizer

Manufacturer
Empack Spraytech Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:45:51

Label at a glance#

ProductFoam Hand Sanitizer
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

Place 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 (v/v )

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

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

  • Place 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

Aloe Barbadensis Leaf Juice, Aqua, Bis-PEG-12 Dimethicone, Ceteareth-25, Glycerin, Isobutane, Stearyl alcohol.

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 - Foaming Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Foaming Hand Sanitizer

Alcohol Antiseptic 70%

Optional size ranges between 100g to 325g

Principal display panel - Foaming H SanitizerPrincipal display panel - Foaming H Sanitizer

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
50021-00750021-007-01, 50021-007-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CETEARETH-258FA93U5T67IACT
STEARYL ALCOHOL2KR89I4H1YIACT
BIS-PEG-12 DIMETHICONE (70 MPA.S)2JDK5W22H4IACT
ALOE VERA LEAFZY81Z83H0XIACT
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
20af6032-970d-033b-e063-6294a90ab74d1353660d-a317-4aee-966f-2c1bf829efad2024-12-12WarningsExact identifier
spl id: 20af6032-970d-033b-e063-6294a90ab74d
spl set id: 1353660d-a317-4aee-966f-2c1bf829efad

Reported adverse events (FAERS/openFDA)#

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