FDA.reportPublic FDA data

Antibacterial

Manufacturer
Inopak, Ltd
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:41:57

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 children's reach

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 ingredients

INACTIVE INGREDIENT SECTION

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

Pro-Source individual label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pro-source individual label

PRO-SOURCE                                                                                                     PACKAGED FOR USE IN A

DISTRIBUTORS                                                                                                  WALL MOUNT

Your Professional Source for Janitorial Supplies                                  DISPENSER

Anti-Bacterial Hand Soap

High Foaming

Antiseptic Hand and Body Wash

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.

5063-PS                                Rev. 1.1                                PDI-3605

Sold By: Pro-Source Distributors, Inc.

2613 – 11th Street, Rockford, IL 61109                      Net Contents:

815-229-9555 • www.pdi1supply.com             1000ml 33.8 OZ

Pro-Source individual labelPro-Source individual label

Pro-Source case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRO-SOURCE

DISTRIBUTORS

Your Professional Source for Janitorial Supplies 

High Foaming

Antiseptic Hand and Body Wash

Sold By: Pro-Source Distributors, Inc.

2613 – 11th Street, Rockford, IL 61109     

815-229-9555

www.pdi1supply.com

Net Contents:

6/1000 mL BAGS

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.

5063-PS-CS         Rev. 1.1                                PDI-3605

Pro-Source case labelPro-Source case label

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
58575-51458575-514-01, 58575-514-02

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
CHLOROXYLENOL0F32U78V2QACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
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
c2b58fdf-38c5-2df6-e053-2995a90aca0410c72f82-1958-4b71-8ac4-0eeea77c29c02021-05-19WarningsExact identifier
spl set id: 10c72f82-1958-4b71-8ac4-0eeea77c29c0

Reported adverse events (FAERS/openFDA)#

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