Label: FOAMING ALCOHOL HAND SANITIZER- ethyl alcohol solution

  • NDC Code(s): 78641-688-50, 78641-688-78
  • Packager: Global Equipment Company
  • 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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  • ACTIVE INGREDIENT

    Active Ingredient - Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose - Antbacterial Agent

  • INDICATIONS & USAGE

    Uses - Hand sanitizer to help reduce bacteria on the skin that could cause disease.

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

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

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    Primary Label

  • INGREDIENTS AND APPEARANCE
    FOAMING ALCOHOL HAND SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78641-688
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISODIUM EDTA-COPPER CU-64 (UNII: 4J875U5U11)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78641-688-78950 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2020
    2NDC:78641-688-501200 mL in 1 BAG; Type 0: Not a Combination Product03/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/16/2020
    Labeler - Global Equipment Company (001472216)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(78641-688)
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