Label: FOAMING INSTANT HAND SANITIZER- 0.13% benzakonium chloride liquid

  • NDC Code(s): 71303-207-31, 71303-207-41
  • Packager: RJ Schinner
  • 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 August 24, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Dosage and Administration Section

    Directions: Apply a small amount to palm. Briskly rub, covering hands with product until dry.

  • Inactive Ingredient Section

    Inactive Ingredients: Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Tocopheral Acetate, Peg-& Glyceral Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA

  • Indications and Usage Section

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

  • Keep Out Of Reach Of Children Section

    Keep Out Of Reach Of Children: If swallowed, contact a physician or poison control center.

  • OTC Purpose Section

    Purpose: Antibacterial Agent

  • OTC Active Ingredient Section

    Active Ingredient: Benzalkonium Chloride 0.13% w/w

  • Warnings Section

    Warnings: For External Use Only

    Contact with Eyes: If contact occurs, flush with water

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

  • Primary Display Label

    Primary Display Label

  • INGREDIENTS AND APPEARANCE
    FOAMING INSTANT HAND SANITIZER 
    0.13% benzakonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71303-207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71303-207-411000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2017
    2NDC:71303-207-311000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2017
    Labeler - RJ Schinner (023432909)
    Registrant - Kutol Products, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products, Inc.004236139manufacture(71303-207)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!