ANTIBACTERIAL- chloroxylenol liquid 
Inopak, Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pro-Source Antibacterial Hand Soap

Active Ingredient

Parachlorometaxylenol 0.3%

Purpose

Antiseptic

Use

  • 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.

When Using

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

Stop use

  • 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

  • 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.

Pro-Source individual label

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

815-229-9555 • WWW.PDI1SUPPLY.COM             1000ml 33.8 OZ

Pro-Source individual label

Pro-Source case label

PRO-SOURCE

DISTRIBUTORS

Your Professional Source for Janitorial Supplies 

High Foaming

Antiseptic Hand and Body Wash

Sold By: Pro-Source Distributors, Inc.

2613 – 11 th 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 label

ANTIBACTERIAL 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-514
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58575-514-011000 mL in 1 BAG; Type 0: Not a Combination Product01/01/201805/19/2021
2NDC:58575-514-026000 mL in 1 CASE; Type 0: Not a Combination Product01/01/201805/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/201805/19/2021
Labeler - Inopak, Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd194718243manufacture(58575-514)

Revised: 5/2021
 
Inopak, Ltd