FDA.reportPublic FDA data

STERiZAR

Manufacturer
Unicorn Media Partners LLC
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:08

Label at a glance#

ProductSTERiZAR Advanced Barrier Control
Active ingredientBenzalkonium Chloride
Label structure10 sections

Dosage and administration

Wipe hands for 30 seconds then leave to air dry. Always reseal wipe container after use.

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

INDICATIONS & USAGE SECTION

Antibacterial Hand Wipes for Rapid Kill of Bacteria on Skin. 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

  • Wipe hands for 30 seconds then leave to air dry.
  • Always reseal wipe container after use.

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 - 200 Wipe Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 79310-305-26

STERiZAR®
Advanced Barrier Control

Antibacterial Hand Wipes

Specially formulated to kill
harmful bacteria in seconds

ALCOHOL
FREE

Kills 99.999% of germs

Ideal for killing bacteria on skin.
No need to rinse

Contents: 200 average

• HALAL MONITORING •
COMMITTEE - UK

PRINCIPAL DISPLAY PANEL - 200 Wipe Bag Label
PRINCIPAL DISPLAY PANEL - 200 Wipe Bag Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2463930benzalkonium chloride 1.6 % Medicated PadPSN2
2463930benzalkonium chloride 16 MG/ML Medicated PadSCD2
2463930benzalkonium chloride 1.6 % Medicated PadSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79310-305-262023-07-28C16284748780-10191ceaa-6818-198a-e063-dbdaa90aec3eSTERiZAR ® Advanced Barrier Control

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79310-305-26STERiZAR Advanced Barrier Control200 in 1 BAGCLOTH2002
79310-305-26STERiZAR Advanced Barrier Control2.35 mL in 1 APPLICATORCLOTH2.352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79310-305STERIZAR ADVANCED BARRIER CONTROL (BENZALKONIUM CHLORIDE) CLOTH [UNICORN MEDIA PARTNERS LLC]2Legacy NDC, 2 package rows20220119_3798eea5-e116-48b3-8ea3-d77dfda94cca.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
79310-30579310-305-26

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
206bf653-c745-411c-9ac8-4849f4a773b63798eea5-e116-48b3-8ea3-d77dfda94cca2022-01-14WarningsExact identifier
spl id: 206bf653-c745-411c-9ac8-4849f4a773b6
spl set id: 3798eea5-e116-48b3-8ea3-d77dfda94cca

Reported adverse events (FAERS/openFDA)#

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