Label: MEDICAL GRADE HAND SANITIZER- alcohol gel

  • 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 July 20, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Ethyl alcohol (70% v/v)

  • Purpose

    Antiseptic

  • Inactive ingredients

    Carbomer, Glycerin, Propylene Glycol, Aminomethyl Propanol, Isopropyl Myristate, Tocopheryl Acetate, Purified Water, Fragrance.

  • Use (s)

    Hand sanitizer to help reduce 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 our 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 - 236 ml Bottle Label

    ADVANCED PROTECTION
    KILLS VIRUSES AND GERMS

    SCIENTIFIC
    SOLUTIONS

    MEDICAL GRADE GEL HAND SANITIZER

    70% ALCOHOL

    (236ml/8oz)

    PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    MEDICAL GRADE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77110-500-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    2NDC:77110-500-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    3NDC:77110-500-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E07/20/2020
    Labeler - Biominerales Pharma (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma117489663MANUFACTURE(77110-500)
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