ANTIBACTERIAL- chloroxylenol liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
Available from:
Inopak, Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Handwash to help reduce bacteria on the skin that can potentially cause disease. Recommended for repeated use. - Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
Authorization status:
OTC monograph not final
Authorization number:
58575-508-01, 58575-508-02

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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Bortek Foaming Hand Soap 508

Active Ingredient

Parachlorometaxylenol 0.3%

Purpos e

Antiseptic

Us e

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

Us es

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

Us es

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

ANTIBACTERIAL

chloroxylenol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 575-50 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RO XYLENO L (UNII: 0 F32U78 V2Q) (CHLOROXYLENOL - UNII:0 F32U78 V2Q)

CHLOROXYLENOL

3 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

CO CAMIDO PRO PYL DIMETHYLAMINE (UNII: L36 BM7DG2T)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

Alco ho l (UNII: 3K9 9 58 V9 0 M)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Inopak, Ltd

FD&C RED NO . 4 (UNII: X3W0 AM1JLX)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:58 575-50 8 -

10 0 0 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 18

2

NDC:58 575-50 8 -

40 0 0 mL in 1 CASE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 1/0 1/20 18

Labeler -

Inopak, Ltd (194718243)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ino pak, Ltd

19 4718 243

ma nufa c ture (58 575-50 8 )

Revised: 2/2020

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