ANTIBACTERIAL - 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.

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Kissable Lavender Fields - Hand Soap Antibacterial

Benzalkonium Chloride - 0.13%

Purpose: Antibacterial

Direction

Warning

For external use only - Hands only

Stop use and ask a doctor

When using this product

Keep out of reach of children

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Sodium Lauroamphoacetate , Polyquatemium-7, Citric Acid, Glycerin,

Aloe Barbadensis leaf Extract , Fragrance, Teocopheryl Acetate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 40(Cl 16035)

Uses for handwashing or decrease bacteria to the skin

lavelave_2

ANTIBACTERIAL  
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-424
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 LAUROAMPHOACETATE (UNII: SLK428451L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-424-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/05/2021
Labeler - Brands International Corporation (243748238)
Registrant - Brands International Corporation (243748238)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(50157-424)

Revised: 3/2021
Document Id: bd11ce19-2465-40b7-e053-2995a90ad425
Set id: bcfc5d73-369a-411c-e053-2a95a90ac862
Version: 2
Effective Time: 20210308
 
Brands International Corporation