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 can potentially 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 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

Do not get into eyes. 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 ingredients

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

Individual label

Rev 1.0                                                 A FAMILY COMPANY SINCE 1967               800.626.7835

Part#: 5063-Bortek                                                                                                          sweeperland.com

Bortek®

                                                INDUSTRIES, INC.

FOAMING HAND SOAP

Antibacterial Hand Wash with Moisturizers

YOUR CLEANING SOLUTIONS RESOURCE

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, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Questions? Call 800-626-7835 or visit our website sweeperland.com

Reorder Item #28130103                               Net Contents: 1000 ml

Multi-pack label

Rev 1.0                                                 A FAMILY COMPANY SINCE 1967               800.626.7835

Part#: 5063-BortekCS                                                                                                     sweeperland.com

Bortek®

INDUSTRIES, INC.

FOAMING HAND SOAP

Antibacterial Hand Wash with Moisturizers          MADE IN THE USA

YOUR CLEANING SOLUTIONS RESOURCE

Corporate Headquarters

4713 Gettysburg Road

Mechanicsburg, PA 17055

EQUIPMENT       PARTS   RENTALS              SERVICE               SUPPLIES

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, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Questions? Call 800-626-7835 or visit our website sweeperland.com

Reorder Item #28130103                               Net Contents: 6 x 1000 ml            ANTIBACTERIAL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-508
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: 58575-508-01	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-508-02	4000 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(58575-508)