BEN E. KEITH FIHS- benzalkonium chloride solution 
Ben E. Keith Foods

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.

----------

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial Agent

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

  • Avoid contact with eyes

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

Inactive Ingredients Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E), PEG-7 Glyceryl Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA.

Representative label and principal display panel

ALCOHOL-FREE

BEN E. KEITH

ESSENTIALS

FOAMINIG

INSTANT HAND

SANITIZER

REORDER

#885610

Net Contents: 1000 mL (33.8 Fl. Oz.)

DISTRIBUTED BY Ben E. Keith Foods

FT. WORTH, TX 76101

representative label

BEN E. KEITH FIHS 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50980-207
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)  
EDETATE SODIUM (UNII: MP1J8420LU)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50980-207-121000 mL in 1 BAG; Type 0: Not a Combination Product05/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/31/2016
Labeler - Ben E. Keith Foods (007929748)

Revised: 6/2022
Document Id: 2e833f78-5ede-4e76-a1c7-6523cd419411
Set id: 4ca21370-1ecf-42c6-9c32-79cf994c336b
Version: 3
Effective Time: 20220603
 
Ben E. Keith Foods