Puresan Antibacterial Liquid Soap

Puresan Antibacterial Liquid by

Drug Labeling and Warnings

Puresan Antibacterial Liquid by is a Otc medication manufactured, distributed, or labeled by Avro Enterprises LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURESAN ANTIBACTERIAL LIQUID- chloroxylenol liquid 
Avro Enterprises LLC

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 Antibacterial Liquid Soap

Drug Facts

Active ingredient

Chloroxylenol 0.3% w/w

Purpose

Antiseptic

Uses

• For handwashing to help reduce bacteria on the skin.
• Recommended for repeated use.

Warnings

For external use only.

When using this product keep away from eyes. 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.
• Lather vigorously for at least 15 seconds.
• Rinse with water and dry thoroughly.

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

Distributed By: Puresan

24 Ames Blvd., Hamburg, NJ 07419

855.500.8080 puresanusa.com

Antibacterial Liquid Soap

With Moisturizers

Contains Chloroxylenol 0.3%

33.8 fl.oz. (1000 mL) Refill Bag LIQUID

PURESAN ANTIBACTERIAL LIQUID 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73062-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
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: 73062-408-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	08/20/2021	06/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/20/2021	06/26/2024

Labeler - Avro Enterprises LLC (804030166)

Revised: 1/2023

Document Id: f27977ed-9611-3c5b-e053-2995a90a419d

34390-5

Set id: ca039354-6456-5a42-e053-2995a90a8106

Version: 2

Effective Time: 20230102