FDA.reportPublic FDA data

STERiZAR

Manufacturer
Unicorn Media Partners LLC
Effective date
2020-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:50

Label at a glance#

ProductSTERiZAR Advanced Barrier Control
Active ingredientBenzalkonium Chloride
Label structure10 sections

Dosage and administration

Squeeze gently approximately 2 ml (one shot) on physically clean hands. Rub into the hands skin for at least 30 second ensuring that all areas are covered until dry.

Storage and handling

Store in cool dry area. Avoid freezing Store at 15-30 C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 1.6 %

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand Sanitizer Foam. For Hand Sanitizing to Decrease Bacteria On Skin. Safe for Repeated Use. For use when soap and water not available.

Warnings

WARNINGS SECTION

For external use only. Keep away from heat. Flammable, Keep Away from Heat and Flame

Do not use

OTC - DO NOT USE SECTION

  • On open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rush occurs These may be sign of serious medical conditions.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • Squeeze gently approximately 2 ml (one shot) on physically clean hands.
  • Rub into the hands skin for at least 30 second ensuring that all areas are covered until dry.

Other information

STORAGE AND HANDLING SECTION

  • Store in cool dry area.
  • Avoid freezing
  • Store at 15-30 C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Amines, C12-14 Alkyl dimethyl, Decyl Dimethyl Ammonium Chloride, N-oxides, Purified Water, Sodium Ethyl Hexyl Sulfate.

SPL UNCLASSIFIED SECTION

Imported and distributed by
Unicorn Media Partners LLC
41 E. Sunrise Hwy.
Lindenhurst, NY 11757

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 79310-304-23

STERiZAR®
Advanced Barrier Control

Hand Foam
Sanitizer

Specially formulated to kill
harmful bacteria in seconds

ALCOHOL
FREE

Kills 99.999% of germs

Remains effective after application for at
least 6 hours using Advanced Barrier Control.
No need to rinse. Moisturizing foam that
is kind to your hands.

3.4 FL OZ (100 mL)

• HALAL MONITORING •
COMMITTEE - UK

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79310-304-212023-01-30C16284748780-1f386c649-da15-0266-e053-dadaa90a7c1aSTERiZAR ® Advanced Barrier Control
79310-304-222023-01-30C16284748780-1f386c649-da15-0266-e053-dadaa90a7c1aSTERiZAR ® Advanced Barrier Control
79310-304-232023-01-30C16284748780-1f386c649-da15-0266-e053-dadaa90a7c1aSTERiZAR ® Advanced Barrier Control
79310-304-252023-01-30C16284748780-1f386c649-da15-0266-e053-dadaa90a7c1aSTERiZAR ® Advanced Barrier Control

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79310-304-21STERiZAR Advanced Barrier Control5000 mL in 1 BOTTLE, PUMPSPRAY50001
79310-304-22STERiZAR Advanced Barrier Control500 mL in 1 BOTTLE, PUMPSPRAY5001
79310-304-23STERiZAR Advanced Barrier Control100 mL in 1 BOTTLE, PUMPSPRAY1001
79310-304-25STERiZAR Advanced Barrier Control50 mL in 1 BOTTLE, PUMPSPRAY501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79310-304STERIZAR ADVANCED BARRIER CONTROL (BENZALKONIUM CHLORIDE) SPRAY [UNICORN MEDIA PARTNERS LLC]1Legacy NDC, 4 package rows20201105_16cb571d-0e9e-4558-a1e5-e2649a1d9bf1.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
79310-30479310-304-25, 79310-304-23, 79310-304-22, 79310-304-21

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
Benzalkonium ChlorideF5UM2KM3W7ACTIB
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
SODIUM ETHASULFATE12838560LIIACT
WATER059QF0KO0RIACT

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
e7aba85f-6b3a-4e3e-9165-4500ce392fce16cb571d-0e9e-4558-a1e5-e2649a1d9bf12020-11-04WarningsExact identifier
spl id: e7aba85f-6b3a-4e3e-9165-4500ce392fce
spl set id: 16cb571d-0e9e-4558-a1e5-e2649a1d9bf1

Reported adverse events (FAERS/openFDA)#

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