FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Atlanta Supersource, Inc.,
Effective date
2022-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:04

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

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

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#

Ideal Foam Hand Sanitizer

SPL UNCLASSIFIED SECTION

Product Description: Non-Flammable, Non-Toxic Hand Sanitizer for everyday use. Will not dry hands. Reduces Common Harmful Germs and Bacteria. FDA approved formulation, manufactured in an FDA Registered Facility. For use when soap and water is not always available.

NDC: 75056-0008-01

Produced for WALBRO by:

Atlanta Supersource, Inc.

3655 Kennesaw 75 Parkway:

Suite 100

Kennesaw, Georgia 30144

EMERGENCY RESPONSE PROVIDED BY: Chemtrec 1.800.424.9300

Item Number: CLE224

Active Ingredient (s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

keep our to eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

If irritation or rash occurs.

Keep out of reach of children

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide

Glycereth-17, Citric Acid Monohydrate - these are not on the Product Data Sheet and Katie explained they do not nee to be listed.

Questions or Comments?

OTC - QUESTIONS SECTION

Call us at 833.423.0006

Ideal Hand Sanitizer Foam

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Net Contents 1 Gallon (3.78L)Net Contents 1 Gallon (3.78L)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN3
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD3
1038799benzalkonium chloride 0.1 % Topical FoamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75056-008-012024-01-30C16284748780-11030e365-0b50-111a-e063-dadaa90a10e2Ideal Foam Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75056-008-01Hand Sanitizer3785 g in 1 BOTTLE, PLASTICAEROSOL, FOAM37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75056-008HAND SANITIZER (HAND SANITIZER FOAM BAC) AEROSOL, FOAM [ATLANTA SUPERSOURCE, INC.,]3Legacy NDC, 1 package rows20221206_ac9d8c36-2319-52a4-e053-2995a90a4fb9.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75056-00875056-008-01

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
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT

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
ef19e9ed-654c-1f8a-e053-2a95a90a315aac9d8c36-2319-52a4-e053-2995a90a4fb92022-12-05WarningsExact identifier
spl id: ef19e9ed-654c-1f8a-e053-2a95a90a315a
spl set id: ac9d8c36-2319-52a4-e053-2995a90a4fb9

Reported adverse events (FAERS/openFDA)#

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