PURESAN ANTIBACTERIAL LIQUID- parachlorometaxylenol liquid

Puresan Antibacterial Liquid by

Drug Labeling and Warnings

Puresan Antibacterial Liquid 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% w/w

Purpose

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.

When using

 Keep out of eyes, ears, or mouth. 

Stop use

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

Children

 Keep out of reach of children. 

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 Ingredient

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

• MADE IN THE USA:

  Antibacterial

  Liquid Soap

  With Moisturizers

  1000 ml

  Refill Bag LIQUID puresan

  Item# s1000 cleaning innovations

• 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 Case label

 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

INGREDIENTS AND APPEARANCE

PURESAN ANTIBACTERIAL LIQUID 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-408
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 ACETATE (UNII: DSO12WL7AU)
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-408-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-408-02	8000 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(58575-408)