Label: ADVANCED 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 May 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug facts

  • Active Ingredient (s)

    Ethyl alcohol 80% v/v

  • Purpose

    Antiseptic

  • Use(s)

    Hand Sanitizer to help reduce bacteria on the skin when water and soap are not available.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

    Do not use

    • Children under 6 years of a age should be supervise when using this product
    • 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 for more than 72 hours, consult a doctor.

    Keep out of reach of Children. If swallowed, get medical help or contact a 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 or misuse.
  • OTHER INFORMATION

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive Ingredients

    glycerin, hydrogen, peroxide, purified water USP

  • PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label

    BIOMINERALES
    PHARMA

    ADVANCED
    HAND SANITIZER

    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.

    Disposal:
    Dispose of contents/ container to an approved waste disposal plant.

    Active ingredients
    Ethyl Alcohol 80%
    Glycerin 1.45%
    Hydrogen Peroxide .125%
    Sterilized water 18.425%

    Net Contents 3785 ML

    Made in the USA

    PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.0145 mL  in 1 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.00125 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.18425 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77110-100-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E05/10/2020
    Labeler - Biominerales Pharma, LLC (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma, LLC117489663MANUFACTURE(77110-100)
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