FDA.reportPublic FDA data

INOFOAM Antibacterial

Manufacturer
Inopak, Ltd
Effective date
2022-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:03

Label at a glance#

ProductINOFOAM Antibacterial Foaming Hand Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.13% (w/w)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop or if condtion 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
  • Wash both hands thoroughly for 15 seconds.
  • Rince under running water and dry thoroughly.

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Laurtrimonium Chloride, Cocamidopropyl Betaine, PEG-6 Cocamide, Cocamidopropyl PG-Dimonium Chloride Phosphate, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Methylisothiazolinone, Iodopropyl Butylcarbamate, Red 4.

SPL UNCLASSIFIED SECTION

Manufactured forr Inopak, LTD., Ringwood, NJ 07456

1-800-767-7725 • www.inopak.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INOFOAM

Antibacterial Foaming Hand Wash

NET CONTENTS: 33.8 FL. OZ. (1000 ML)

58575-526 Inofoam HW 1000mL 062258575-526 Inofoam HW 1000mL 0622

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58575-526-012024-01-30C16284748780-11030e365-2ebb-111a-e063-dadaa90a10e2INOFOAM Antibacterial Foaming Hand Wash (BZK formula)
58575-526-422024-01-30C16284748780-11030e365-2ebb-111a-e063-dadaa90a10e2INOFOAM Antibacterial Foaming Hand Wash (BZK formula)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58575-526-01INOFOAM AntibacterialFoaming Hand Wash1000 mL in 1 POUCHLIQUID10001
58575-526-42INOFOAM AntibacterialFoaming Hand Wash3785 mL in 1 JUGLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58575-526INOFOAM ANTIBACTERIAL FOAMING HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [INOPAK, LTD]1Legacy NDC, 2 package rows20220702_e29c3814-4b82-6b21-e053-2a95a90a6ed1.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-52658575-526-01, 58575-526-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
FD&C RED NO. 4X3W0AM1JLXIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
e29c3814-4b81-6b21-e053-2a95a90a6ed1e29c3814-4b82-6b21-e053-2a95a90a6ed12022-06-29WarningsExact identifier
spl id: e29c3814-4b81-6b21-e053-2a95a90a6ed1
spl set id: e29c3814-4b82-6b21-e053-2a95a90a6ed1

Reported adverse events (FAERS/openFDA)#

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