FDA.reportPublic FDA data

Lite nFoamy E3 Hand Sanitizer

Manufacturer
Spartan Chemical Company
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:54

Label at a glance#

ProductLite nFoamy E3 Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Hands must be washed and rinsed with potable water before use. Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develops, or if condition persists for more than 72 hours.

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

  • Hands must be washed and rinsed with potable water before use.
  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.

Other Information

SPL UNCLASSIFIED SECTION

  • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
  • Do not contaminate water, food or feed by storage and disposal.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxethyl Cocamine Oxide, Glycereth-17-Cocoate, Citric Acid

Questions?

OTC - QUESTIONS SECTION

1 -800-537-8990

Principal Display Panel - Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lite n Foamy E3 Hand Sanitizer GallonLite n Foamy E3 Hand Sanitizer Gallon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN6
1493160Lite 'n Foamy 0.1 % Topical FoamPSN6
1493160benzalkonium chloride 1 MG/ML Topical Foam [Lite 'N Foamy]SBD6
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD6
1038799benzalkonium chloride 0.1 % Topical FoamSY6
1493160Lite 'N Foamy 0.1 % Topical FoamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64009-334-052019-11-27C16284748780-19855e2a2-4314-60a7-e053-dbdaa90a05bd2754e9bf-8c81-45b6-b243-993b9c4f9956
64009-334-082019-11-27C16284748780-19855e2a2-4314-60a7-e053-dbdaa90a05bd2754e9bf-8c81-45b6-b243-993b9c4f9956

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64009-334-05Lite nFoamy E3 Hand Sanitizer3.79 L in 1 CONTAINERSOAP3.796
64009-334-08Lite nFoamy E3 Hand Sanitizer280.2 L in 1 CONTAINERSOAP280.26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64009-334LITE NFOAMY E3 HAND SANITIZER (BENZALKONIUM CHLORIDE) SOAP [SPARTAN CHEMICAL COMPANY]6Current NDC, Legacy NDC, 2 package rows20231220_2754e9bf-8c81-45b6-b243-993b9c4f9956.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W71
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y1
Cetrimonium chlorideINACTIVE INGREDIENTUC9PE95IBP1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
Dihydroxyethyl Cocamine OxideINACTIVE INGREDIENT8AR51R3BL51
Glycereth-17 cocoateINACTIVE INGREDIENT3057VPT0KC1
Laurtrimonium chlorideINACTIVE INGREDIENTA81MSI0FIC1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64009-33464009-334-05, 64009-334-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
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
Lite nFoamy E3 Hand SanitizerBENZALKONIUM CHLORIDESpartan Chemical Company2754e9bf-8c81-45b6-b243-993b9c4f99562023-12-19WarningsExact identifier
ndc (package): 64009-334-08
ndc (package): 64009-334-05
ndc (product): 64009-334
ndc11 (package): 64009033405
ndc11 (package): 64009033408
spl id: 0ce28410-686c-2791-e063-6294a90ac0f5
spl set id: 2754e9bf-8c81-45b6-b243-993b9c4f9956

Reported adverse events (FAERS/openFDA)#

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