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

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

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 – 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

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-514
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-514-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-514-02	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(58575-514)