FDA.reportPublic FDA data

Foaming Hand

Manufacturer
Nice-Pak Products, LLC
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 01:49:55

Label at a glance#

ProductFoaming Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

wet hands  apply palmful to hands  scrub thoroughly  rinse thoroughly

Label contents#

Full prescribing information#

Claims

SPL UNCLASSIFIED SECTION

germ-X

Professional

ANTIBACTERIAL 

FOAMING HAND SOAP

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only: hands only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists 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 
  • apply palmful to hands 
  • scrub thoroughly 
  • rinse thoroughly

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, citric acid, tetrasodium EDTA, sodium benzoate

Claims

SPL UNCLASSIFIED SECTION

Product is NSF registered for us as a hand sanitizer in and around food processing areas.

Adverse event

ADVERSE REACTIONS SECTION

Manufactured By: Vi-Jon, Inc. 8515 Page Ave. St. Louis, Mo 63114

vijonprofessional.com

Adverse event

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11344-224-08

germ-X ®

Professional

ANTIBACTERIAL

FOAMING

HAND SOAP

Helps kill harmful germs

128 FL OZ (1 GAL) 3.79 L

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN18
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD18
1020365benzalkonium chloride 0.13 % Topical FoamSY18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-224-04Foaming Hand750 mL in 1 BOTTLE, PLASTICLOTION75018
11344-224-08Foaming Hand3785 mL in 1 BOTTLE, PLASTICLOTION378518
11344-224-20Foaming Hand44 mL in 1 BOTTLE, DISPENSINGLOTION4418
11344-224-44Foaming Hand532 mL in 1 BOTTLE, PLASTICLOTION53218
11344-224-45Foaming Hand1150 mL in 1 BOTTLE, PLASTICLOTION115018
11344-224-86Foaming Hand1000 mL in 1 BOTTLE, DISPENSINGLOTION100018
11344-224-96Foaming Hand222 mL in 1 BOTTLE, PUMPLOTION22218

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11344-22411344-224-08, 11344-224-96, 11344-224-44, 11344-224-04, 11344-224-45, 11344-224-20, 11344-224-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
MYRISTAMIDOPROPYLAMINE OXIDE3HSF539C9TIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
Foaming HandBENZALKONIUM CHLORIDENice-Pak Products, LLC2002c182-b4a6-4baa-8497-74570713b8bb2026-03-12Warnings, Adverse reactionsExact identifier
ndc (package): 11344-224-04
ndc (package): 11344-224-20
ndc (package): 11344-224-44
ndc (package): 11344-224-86
ndc (package): 11344-224-45
ndc (package): 11344-224-08
ndc (package): 11344-224-96
ndc (product): 11344-224
ndc11 (package): 11344022408
ndc11 (package): 11344022496
ndc11 (package): 11344022420
ndc11 (package): 11344022486
ndc11 (package): 11344022445
ndc11 (package): 11344022444
ndc11 (package): 11344022404
spl id: 4cd559bd-73d9-fdfb-e063-6294a90a0afe
spl set id: 2002c182-b4a6-4baa-8497-74570713b8bb

Reported adverse events (FAERS/openFDA)#

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