SEOJEON ANTIBACTERIAL WIPES- benzalkonium chloride liquid

Seojeon Antibacterial Wipes by

Drug Labeling and Warnings

Seojeon Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by STRONGHOLD TRADING LLC, SEOJEON CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only

Do not use

● in children less than 2 months of age

● on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children

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

Directions

● Place enough product on hands to cover all surfaces. Rub hands together until dry.

● Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

● Store between 15-30C (59-86F)

● Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water,sodium coco pg-dimonium chloride phosphate , methylpropanediol, laurylpyridinium chloride, caprylhydroxamic acid, alcohol, levulinic acid, sodium levulinate

Package Label

INGREDIENTS AND APPEARANCE

SEOJEON ANTIBACTERIAL WIPES 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80969-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
LEVULINIC ACID (UNII: RYX5QG61EI)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM LEVULINATE (UNII: VK44E1MQU8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80969-501-01	45 g in 1 POUCH; Type 0: Not a Combination Product	02/26/2021
2	NDC: 80969-501-02	90 g in 1 POUCH; Type 0: Not a Combination Product	02/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/26/2021

Labeler - STRONGHOLD TRADING LLC (117694134)

Registrant - SEOJEON CO., LTD (694781990)

Establishment
Name	Address	ID/FEI	Business Operations
SEOJEON CO., LTD		694781990	manufacture(80969-501)