Label: BEN E. KEITH FIHS- benzalkonium chloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated June 3, 2022

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  • 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

    • For external use only

    • 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

    • To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.
  • INACTIVE INGREDIENT

    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

  • INGREDIENTS AND APPEARANCE
    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)
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