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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Inopak (Puresan) Foaming Hand Wash

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 reach of children

  • 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 Ingredient

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

puresan individual label

                                                                                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 label

puresan case label

 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 lable

ANTIBACTERIAL 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-511
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)  
COCAMIDE (UNII: 3YXD33R71G)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58575-511-011000 mL in 1 BAG; Type 0: Not a Combination Product01/01/201808/20/2021
2NDC:58575-511-026000 mL in 1 CASE; Type 0: Not a Combination Product01/01/201808/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/201808/20/2021
Labeler - Inopak, Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd194718243manufacture(58575-511)

Revised: 8/2021
Document Id: ca048cd5-4071-41ef-e053-2995a90a7c49
Set id: 041e6bae-e07a-4063-9172-2f999898dfd2
Version: 4
Effective Time: 20210820
 
Inopak, Ltd