Label: HAND SANITIZER- gel hand sanitizer gel

  • NDC Code(s): 64542-056-35
  • 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.

  • 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, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol.

  • WARNINGS

    Warnings For external use only. FLAMMABLE. Keep away from heat or flame. Do not use in the eyes. If eye contact occurs, flush with water. Stop and ask a doctor if redness and irritation occur and last more than 72 hours.

  • PRINCIPAL DISPLAY PANEL

    Gentle Fresh LabelPrincipal Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    gel hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-056
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64542-056-35118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/09/2020
    Labeler - State Industrial Products (004520987)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(64542-056)
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