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 potentially can 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:
58575-511-01, 58575-511-02

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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Puresan Foaming Hand Wash 511

Active Ingredient

Parachlorometaxylenol 0.3%

Purpos e

Antiseptic

Us e

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

Purpos e

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, 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

Purpos e

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, 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

ANTIBACTERIAL

chloroxylenol liquid

Inopak, Ltd

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 575-511

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 CAMIDE (UNII: 3YXD33R71G)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

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

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

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 575-511-0 1

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 18

2

NDC:58 575-511-0 2

6 0 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 (58 575-511)

Revised: 2/2020

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