Label: HAND SANITIZER- 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 June 11, 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.
  • SPL UNCLASSIFIED SECTION

    Manufactured for and
    Distributed by:
    Biominerales Pharma, LLC
    Boca Raton, Florida 33442

  • PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label

    BIOMINERALES
    PHARMA

    HAND SANITIZER - GEL

    Kills more than 99.99% of germs

    Prevention:
    Keep away from heat / sparks / open flames / hot surfaces.
    No Smoking. Keep container tightly closed.
    Response:
    IF IN EYES: Rinse cautiously with water for several minutes.
    Remove contact lenses, if present and easy to do. Continue rinsing.
    If eye irritation persists: Get medical advice / attention. In case of fire:
    Use dry sand, dry chemical or alcohol - resistant foam for extinction.
    Storage:
    Store in a well-ventilated place. Keep cool. Store Between
    15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above
    40 °C (104 °F)
    Disposal:
    Dispose of contents / container to an approved waste disposal plant.

    Active Ingredients: Ethyl Alcohol 70% v/v

    NDC: 77110-270-01

    Manufactured for and
    Distributed by:
    Biominerales Pharma, LLC
    Boca Raton, Florida 33442
    www.biomineralespharma.com

    Net Contents
    1 Gal. (3,785 mL)

    PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-270
    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:77110-270-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    2NDC:77110-270-06944 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    3NDC:77110-270-02472 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    4NDC:77110-270-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    5NDC:77110-270-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    6NDC:77110-270-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/15/2020
    Labeler - Biominerales Pharma, LLC (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma, LLC117489663MANUFACTURE(77110-270)
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