FDA.reportPublic FDA data

INOFOAM Antibacterial Foaming Hand

Manufacturer
Inopak, Ltd
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:41:57

Label at a glance#

ProductINOFOAM Antibacterial Foaming Hand
Active ingredientCHLOROXYLENOL
Label structure11 sections

Indications and uses

Handwash to help reduce bacteria on the skin that potentially can cause disease. Recommended for repeat use.

Dosage and administration

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.

Label contents#

Full prescribing information#

Drug FactsActive Ingredient

OTC - ACTIVE INGREDIENT SECTION

Parachlorometaxylenol 0.3% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only.
  • Keep out of eyes, ears or moutn. In case of eye contact, fluch eyes with water.
  • Stop use and ask a doctor if irritation and redness develop or if condition persists for more that 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 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 Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, , Water

Questions ?

OTC - QUESTIONS SECTION

Call 1-800-767-7725 or visit our wedsite www.inopak.com

INOFOAM Antibacterial Foaming Hand Wash 1000 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INOFOAM           5063-FL1000

Antibacterial Foaming Hand Wash            With 0.3% PCMX

1000 ml

MADE IN THE USA

INOPAK

Inopak, LTD.       Ringwood, NJ 07456

1-800-762-7725 • www.inopak.com

Drug Facts

Active Ingredient                                         Purpose

Parachlorometaxylenol 0.3% w/w           Antiseptic

Uses

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

Warnings

  • For external use only
  • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
  • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Questions? Call 1-877-703-3044 or visit our website www.encoreindustrial.com

Inopak Antibacterial FoamInopak Antibacterial Foam

Inofoam 18 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INOFOAM           5063-432-02                        Rev. 1.02

Antibacterial Foaming Hand Wash            With 0.3% PCMX

18 fl oz.

(532 ml)

MADE IN THE USA

INOPAK

Inopak, LTD.       Ringwood, NJ 07456

1-800-762-7725 • www.inopak.com

Drug Facts

Active Ingredient                                         Purpose

Parachlorometaxylenol 0.3% w/w           Antiseptic

Uses

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

Warnings

  • For external use only
  • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
  • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Questions? Call 1-877-703-3044 or visit our website www.encoreindustrial.com

5063-432                              Rev. 1.02

Inofoam 18 ozInofoam 18 oz

Inofoam case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibacterial                                      INOFOAM

Foaming Hand Wash                       MADE IN THE USA

O   6/1000 ml Pouches                 O   6/1000 ml Cartridges

      55063-FL1000                                    5063-OS1000

                                                                                                                5063-CS  Rev. 1.0

  040232 65009 3                                 040232 65074 1                              Inopak, LTD.      

                                                                                                                Ringwood, NJ 07456

O   12/18 oz Bottles                       O   4/1 gal Bottles                                  1-800-762-7725

      5063-432-02                                5063-420-03                                     www.inopak.com

  040232 65061 1                                040232 65062 8                               INOPAK

Inofoam caseInofoam case

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-50658575-506-01, 58575-506-18, 58575-506-42, 58575-506-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO DIETHANOLAMIDE92005F972DIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
WATER059QF0KO0RIACT

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
bb6751ad-342c-9cdd-e053-2995a90a9dd4367dfe6f-740f-445b-b8d0-2a483391b6e12021-02-15WarningsExact identifier
spl set id: 367dfe6f-740f-445b-b8d0-2a483391b6e1

Reported adverse events (FAERS/openFDA)#

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