Label: HAND SANITIZER solution

  • NDC Code(s): 64542-207-17, 64542-207-41, 64542-207-46, 64542-207-91
  • Packager: State Industrial Products
  • 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

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  • DOSAGE & ADMINISTRATION

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

  • INDICATIONS & USAGE

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

  • ACTIVE INGREDIENT

    Active Ingredient Benzalkonium Chloride 0.13% v/v

  • WARNINGS

    Warnings For external use only. 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

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

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Propylene Glycol, Fragrance, Tocopheryl Acetate, Tetrasodium EDTA, Cocamidoprpyl Betaine, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

  • PURPOSE

    Purpose Antibacterial Agent

  • PRINCIPAL DISPLAY PANEL

    State Gentle Fresh

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    PROPYLENE GLYCOL 1-MYRISTATE (UNII: 5G38I12XFT)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64542-207-411000 mL in 1 BAG; Type 0: Not a Combination Product02/14/2019
    2NDC:64542-207-1750 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2019
    3NDC:64542-207-46500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2019
    4NDC:64542-207-91547 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/14/2019
    Labeler - State Industrial Products (004520987)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(64542-207)
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