ANTIBACTERIAL- chloroxylenol liquid

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-511-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-511-02	6000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2018

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-511)