Label: HAND SANITIZER- foaming alcohol hand sanitizer solution

  • NDC Code(s): 64542-688-17, 64542-688-41
  • Packager: State Industrial Product
  • 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 Ethyl Alcohol 62% v/v

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Purpose Antibacterial Agent

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

  • WARNINGS

    Warnings For external use only. FLAMMABLE. Keep away from heat or flames. Avoid contact with eyes. If eye 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.

  • PRINCIPAL DISPLAY PANEL

    State Principal LabelPrincipal Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    foaming alcohol hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-688
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64542-688-411000 mL in 1 BAG; Type 0: Not a Combination Product11/21/2017
    2NDC:64542-688-1750 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/21/2017
    Labeler - State Industrial Product (004520987)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(64542-688)
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