ANTIBACTERIAL  2X- benzalkonium chloride liquid 
Brands International Corporation

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.

----------

Benzalkonium Chloride - 0.13%

Purpose: Antibacterial

Direction

For external use only

When using this product

Stop use and ask a doctor if irritation or redness develops

Keep out of reach of children

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

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

Uses for handwashing or decrease bacteria to the skin

16-16

2X

ANTIBACTERIAL   2X
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-016-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/08/2016
Labeler - Brands International Corporation (243748238)
Registrant - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(50157-016)

Revised: 8/2021
Document Id: ca7b4f22-7472-d16f-e053-2a95a90a95cc
Set id: f4baf52f-7632-4d6c-bbd0-9e883d5afb4f
Version: 3
Effective Time: 20210826
 
Brands International Corporation