Label: PROCLEAN HAND SANITIZER- isopropyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 September 9, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Isopropyl Achohol 70%

  • Purpose

    Antiseptic

  • Inactive ingredients

    Water (aqua), carbomer, glycerin, propylene glycol, hydrogen peroxide, aminomethyl propanol

  • Use(s)

    Hand sanitizer to help reduce the bacteria that potentially can cause disease. For use when water and soap 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 or on open skin wounds.

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    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 poison control center right away.

  • Directions

    -
    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    -
    Supervise children under 6 years of age when using this product to avoid swallowing
  • PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

    PROCLEAN

    HAND SANITIZER GEL

    This product should be used as part
    of the daily hand cleansing routine

    70% ISOPROPYL ALCOHOL
    Fights germs and bacteria

    1 GAL (3.79 L)

    MADE IN CANADA
    NDC#77110-220-01

    PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROCLEAN HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77110-220-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
    2NDC:77110-220-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
    3NDC:77110-220-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/15/2020
    Labeler - Biominerales Pharma (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma117489663MANUFACTURE(77110-220)
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