FDA.reportPublic FDA data

ASSURED

Manufacturer
Greenbrier International Inc
Effective date
2015-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:32:46

Label at a glance#

ProductASSURED Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

■ for washing hands to decrease bacteria on the skin ■ recommended for repeated use.

Dosage and administration

■ wet hands thoroughly with product and rub into skin until dry ■ for children under 6, use only under adult supervision ■ not recommended for infants ■ no rinsing required.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ for washing hands to decrease bacteria on the skin ■ recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes. If contact occurs, flush eyes with water.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

irritation or rash develops and continues for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ wet hands thoroughly with product and rub into skin until dry ■ for children under 6, use only under adult supervision ■ not recommended for infants ■ no rinsing required.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetrimonium chloride, disodium cocoamphodiacetate, dimethicone copolyol, fragrance, tocopherol acetate

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-0315-72020-01-31C16284748780-19d75b9d0-a0e7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-0315ASSURED FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [GREENBRIER INTERNATIONAL INC]1Legacy NDC20150311_10e56748-2aaa-42b6-8d28-9877211f53c8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBP1
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-031533992-0315-7

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii candidate
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
41702b1a-eefa-4f1d-b9bb-9f280c8f1bd210e56748-2aaa-42b6-8d28-9877211f53c82015-03-09WarningsExact identifier
spl id: 41702b1a-eefa-4f1d-b9bb-9f280c8f1bd2
spl set id: 10e56748-2aaa-42b6-8d28-9877211f53c8

Reported adverse events (FAERS/openFDA)#

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