Antibacterial

Manufacturer
Inopak, Ltd
Effective date
2020-02-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:41:56

Label at a glance#

ProductAntibacterial
Active ingredientCHLOROXYLENOL
Label structure11 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Parachlorometaxylenol 0.3%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • 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.

When using

OTC - WHEN USING SECTION

  • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Stop use

OTC - STOP USE SECTION

  • 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

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

  • 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 Ingredient

INACTIVE INGREDIENT SECTION

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

puresan individual label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

                                                                                Avro-218

Antibacterial

Foaming 0.3% PCMX

Hand Wash

1000 mL

Refill Bag FOAM

Item# 218                                            puresan

MADE                                                   cleaning innovations

IN THE USA

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, Fragrance, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Rev. 1.1

PO Box 170, Sparta NJ 07871

855.500.8080 • puresanusa.com

Puresan individual labelPuresan individual label

puresan case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 puresan                                                                              puresanusa.com             

 cleaning innovations                                                      (855) 500-8080

ITEM # 218

PURESAN Antibacterial 1000ml Foam Soap

Refill Bag Case of 6                                                           37654 69790

QTY 6

1000ml refills per case

AVRO-218-CS    

                                                                                Avro-218

Antibacterial

Foaming 0.3% PCMX

Hand Wash

1000 mL

Refill Bag FOAM

Item# 218                                            puresan

MADE                                                   cleaning innovations

IN THE USA

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, Fragrance, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Rev. 1.1

PO Box 170, Sparta NJ 07871

855.500.8080 • puresanusa.com

puresan case lablepuresan case lable

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-51158575-511-01, 58575-511-02

Ingredients#

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

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

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
ca048cd5-4071-41ef-e053-2995a90a7c49041e6bae-e07a-4063-9172-2f999898dfd22021-08-20WarningsExact identifier
spl set id: 041e6bae-e07a-4063-9172-2f999898dfd2

Reported adverse events (FAERS/openFDA)#

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