Label: 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 July 9, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Isopropyl alcohol (70% v/v)

  • Purpose

    Antiseptic

  • Inactive ingredients

    Purified Water, Glycerin, Carbomer, Triethanolamine, Hydrogen Peroxide, Fragrance.

  • Use (s)

    Hand sanitizer to help reduce bacteria that potentiallycan 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.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Biominerales Pharma, LLC
    Boca Raton, Florida 33442

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    BIOMINERALES
    PHARMA

    Kills more than 99.99 % of germs

    HAND SANITIZER

    4 oz. (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-400
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Trolamine (UNII: 9O3K93S3TK)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77110-400-05118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E07/15/2020
    Labeler - Biominerales Pharma (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma117489663MANUFACTURE(77110-400)
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