Label: INSTANT HAND SANITIZER- GEL-TYPE solution

  • 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 February 27, 2014

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% v/v.....Antibacterial Agent

  • INACTIVE INGREDIENT

    Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf, Carbomer, Tocopheryl Acetate (Vitamin E), Aminomethyl Propanol

  • PURPOSE

    For hand cleaning to decrease bacteria on skin that could cause disease. Recommended for repeated use.

  • WARNINGS

    For external use only.

    Flammable. Keep away from heat or flame.

    Do not use in the eyes. In case of contact, immediately flush with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

    Children under 6 years of age should be supervised when using this product.

  • INDICATIONS & USAGE

    For hand cleaning to decrease bacteria on skin that could cause disease.

    Do not use in the eyes. In case of contact, immediately flush with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    53341-056-27.jpg 53341-056-27.jpg

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER (GEL-TYPE) 
    instant hand sanitizer (gel-type) solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53341-056
    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
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53341-056-27800 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/05/2013
    Labeler - Tranzonic Companies (007900020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(53341-056) , analysis(53341-056) , pack(53341-056)
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