Label: FOAMING HAND SANITIZER- ethyl alcohol 62% liquid

  • NDC Code(s): 71303-688-31, 71303-688-41
  • Packager: RJ Schinner
  • 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 Section

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

  • Inactive Ingredient Section

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

  • Indication & Usage Section

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

  • OTC-Keep Out of Reach of Children

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

  • Purpose Section

    Purpose Antibacterial Agent

  • OTC - Active Ingredient Section

    Active Ingredient Ethyl Alcohol 62% v/v

  • Warnings Section

    Warnings

    For external use only.

    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

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    ethyl alcohol 62% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71303-688
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71303-688-311000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
    2NDC:71303-688-411000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2017
    Labeler - RJ Schinner (023432909)
    Registrant - Kutol Products, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products, Inc.004236139manufacture(71303-688)
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