SEOJEON ANTIBACTERIAL WIPES- benzalkonium chloride liquid 
STRONGHOLD TRADING 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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80969-501 Seojeon Antibacterial Wipes

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

80969-501-01 45g Label 1

80969-501-01 45g Label 2

80969-501-02 90g Label 1

80969-501-02 90g Label 2

SEOJEON ANTIBACTERIAL WIPES 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80969-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80969-501-0145 g in 1 POUCH; Type 0: Not a Combination Product02/26/2021
2NDC:80969-501-0290 g in 1 POUCH; Type 0: Not a Combination Product02/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/26/2021
Labeler - STRONGHOLD TRADING LLC (117694134)
Registrant - SEOJEON CO., LTD (694781990)
Establishment
NameAddressID/FEIBusiness Operations
SEOJEON CO., LTD694781990manufacture(80969-501)

Revised: 11/2022
Document Id: ed8de47b-60f2-7ae1-e053-2995a90a1c13
Set id: bcc04208-0f31-2b97-e053-2a95a90ae8ba
Version: 2
Effective Time: 20221115
 
STRONGHOLD TRADING LLC