Label: PRO1TEK HAND SANITIZER GEL- ethyl alcohol 70% liquid

  • 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 9, 2022

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  • Active Ingredient

    Ethyl Alcohol 70%

  • ­­­­­­­­­­­­­­­­­­­­­ Purpose

    Antiseptic

  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For External Use Only. FLAMMABLE. Keep away from heat or flame.

  • Do not use


    In children less than 2 months of age. On open skin wounds.

  • ­­­­­­­­­­­­­­­­­­­Stop use and ask a doctor.

    If irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • When using this product

    Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • ­­­­­­­­­­­­­­­­­­­­­Directions

    Apply a small amount to palm. Bristly rub, covering hand with product until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    Store between 33 and 110 F.

  • Inactive Ingredients

    Water/Eau/Agua, Glycerin, Polyethylene glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (vitamin E), Isopropyl Alcohol, Carbomer, Triisopropanolamine

  • Pro1tek Hand Sanitizer Gel

    labelPackPack

  • INGREDIENTS AND APPEARANCE
    PRO1TEK HAND SANITIZER GEL 
    ethyl alcohol 70% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52232-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2650 mL  in 3785 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52232-107-603785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2022
    2NDC:52232-107-614 in 1 CASE08/01/2022
    23785 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2022
    Labeler - Priority Environmental Solutions Inc. (827067880)
    Registrant - Priority Environmental Solutions Inc. (827067880)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(52232-107)
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