FDA.reportPublic FDA data

Puresan Antibacterial Liquid

Manufacturer
Inopak, Ltd.
Effective date
2020-02-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:41:49

Label at a glance#

ProductPuresan Antibacterial Liquid
Active ingredientCHLOROXYLENOL
Label structure11 sections

Indications and uses

• Handwash to help reduce bacteria on the skin that    potentially can cause disease. • Recommended for repeated use.

Dosage and administration

• Wet hands with water and dispense sufficient     amount of product into cupped palm of hand. • Wash both hands thoroughly for 15 seconds. • Rinse under running water and dry thoroughly.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Parachlorometaxylenol 0.3% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• Handwash to help reduce bacteria on the skin that

   potentially can cause disease.

• Recommended for repeated use.

Warnings

WARNINGS SECTION

• For external use only.

• Keep out of eyes, ears, or mouth. In case of eye 

   contact, flush eyes with water.

• Keep out of reach of children. If swallowed, get

   medical help or contact a Poison Control Center

   right away.

When using

OTC - WHEN USING SECTION

 Keep out of eyes, ears, or mouth. 

Stop use

OTC - STOP USE SECTION

If swallowed, get medical help or contact a Poison Control Center  ight away.

Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 Keep out of reach of children. 

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hands with water and dispense sufficient

    amount of product into cupped palm of hand.

• Wash both hands thoroughly for 15 seconds.

• Rinse under running water and dry thoroughly.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water.

Puresan antibacterial liquid soap single label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADE

IN THE USA

Antibacterial

Liquid Soap

With Moisturizers

1000 ml

Refill Bag LIQUID                                                      puresan

Item# s1000                                            cleaning innovations

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.

• 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 seconds.

• Rinse under running water and dry thoroughly.

Inactive ingredients Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water.

Rev. 1.01

PO Box 170, Sparta NJ 07871

855.500.8080 • puresanusa.com

Puresan single labelPuresan single label

Puresan Case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Puresan                                                                                              puresanusa.com

Cleaning innovations                                                                      (855) 500-8080

ITEM 3 S1000AB-D-C8

PURESAN Antibacterial LOTION soap

1000ml case of 8 refills

QTY 8

1000ml refills per case

AVRO-S1000-CS                Rev: 1.0                                                8  37654 25785  2

Puresan liquid soap case labelPuresan liquid soap case label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-40858575-408-01, 58575-408-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QACTIB
CITRIC ACID ACETATEDSO12WL7AUIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ISOPROPYL ALCOHOLND2M416302IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ca03e6c7-5206-da97-e053-2a95a90ae402c59c1edc-78c6-4ddf-befe-1e39ce30af952021-08-20WarningsExact identifier
spl set id: c59c1edc-78c6-4ddf-befe-1e39ce30af95

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.