ADVANCE ANTIBACTERIAL WIPES- benzalkonium chloride swab 
NP Korea

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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Active Ingredient(s)

Benzalkonium Chloride 0.1% ….………………………Antimicrobial

Purpose

Antimicrobial, Hand Wipes

Use

Warnings

For external use only.

Do not use


Stop use and ask a doctor if 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.

Stop use and ask a doctor if 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

Adults and children 2 years and over;

 Apply wipe thoroughly to hands.

 Allow to dry without wiping.

 Children under 2 years, ask a doctor before use.

Other information

Inactive ingredients

Water, Propylene Glycol, Phenoxyethanol, Glycerin, Sodium Benzoate, Sodium Citrate, Disodium EDTA, Polysorbate 20, Citric

Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate.

Package Label - Principal Display Panel

Advance Antibacterial Wipes

ADVANCE ANTIBACTERIAL WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79178-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1   in 100 
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79178-300-5050 in 1 PACKAGE; Type 0: Not a Combination Product01/19/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/19/2021
Labeler - NP Korea (689007752)
Registrant - NP Korea (689007752)
Establishment
NameAddressID/FEIBusiness Operations
NP Korea689007752label(79178-300)
Establishment
NameAddressID/FEIBusiness Operations
Daol G&C Co., Ltd.693891755manufacture(79178-300)

Revised: 1/2021
Document Id: b9d4829c-c4ee-a157-e053-2995a90aafda
Set id: b9d4aae1-4bf1-7ffb-e053-2995a90a8c94
Version: 1
Effective Time: 20210126
 
NP Korea