DISINFECTING WIPES- benzalkonium chloride cloth 
BI JIE 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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Disinfecting wipes

Disinfecting Wipes

Wipes containing the active ingredient are used topically and externally only.

Disinfecting Wipes

FOR EXTERNAL USE ONLY. Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Stop use and ask a doctor if irritation and redness develop or such 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.

Disinfecting Wipes

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf, Fragrance, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

Disinfecting Wipes

To decrease bacteria on skin that could cause disease. For external use only.

Disinfecting Wipes

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. For children under 6, use only under adult supervision. Not recommended for infants.

Disinfecting Wipes

To decrease bacteria on skin that could cause disease.

Disinfecting Wipes

ACTIVE INGREDIENTS:

Benzalkonium Chloride 0.13%

Disinfecting Wipes

1L NDC: 81344-001-01

1 L label

DISINFECTING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81344-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81344-001-0180 in 1 CONTAINER01/12/2021
11300 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/12/2021
Labeler - BI JIE LLC (098402206)
Registrant - BI JIE LLC (098402206)
Establishment
NameAddressID/FEIBusiness Operations
BI JIE LLC098402206pack(81344-001)
Establishment
NameAddressID/FEIBusiness Operations
Zhangzhou Anyue Sanitation Supplies Co., Ltd.554530435manufacture(81344-001)

Revised: 1/2021
Document Id: b634a916-52b2-1947-e053-2995a90ae6ad
Set id: b634a916-52b1-1947-e053-2995a90ae6ad
Version: 1
Effective Time: 20210112
 
BI JIE LLC