Label: HAND SANITIZER- 62% ethyl alcohol gel

  • 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 and Administration

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

  • Inactive Ingredient Section

    Inactive Ingredients Water, Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Aminomethylpropanol

  • Indications and Usage Section

    Uses For hand cleaning to decrease bacteria on skin.

  • Keep Out Of Reach Of Children Section

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

  • Purpose Section

    Purpose Antibacterial Agent

  • Active Ingredient Section

    Active Ingredient Ethyl Alcohol 62% v/v

  • Warnings Section

    Warnings

    For external use only.

    Flammable. Keep away from head or flame.

    Do not use in the eyes. In case of contact rinse thoroughly.

    Stop and ask a doctor if irritation and redness appears and lasts.

  • Principal Display Label

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    62% ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66608-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66608-056-35118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/04/2019
    Labeler - Kimball Midwest (017906231)
    Registrant - Kutol Products, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products, Inc.004236139manufacture(66608-056)
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