Label: 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 27, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Ethyl alcohol (80% v/v)

  • Purpose

    Antimicrobial

  • Inactive ingredients

    Water(18.025%v/v),Hydrogen Peroxide(0.125%v/v), Carbopol 940 (0.400% v/v), Glycerol (1.450% v/v).

  • Use (s)

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

  • Warnings

    Flammable. Keep away from heat or flame.

    For External use only. When using this product keep our of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water for several minutes. 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 poison control center right away.

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • SPL UNCLASSIFIED SECTION

    Lot : 001 | Exp. : 05 / 2020 | NDC: 77110-200-03

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

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    BIOMINERALES
    PHARMA

    Kills more than 99.99% of germs

    HAND SANITIZER - GEL

    8 oz. (236 mL)

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 18.025 mL  in 100 mL
    Hydrogen Peroxide (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77110-200-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:77110-200-02472 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    3NDC:77110-200-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    4NDC:77110-200-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    5NDC:77110-200-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Biominerales Pharma, LLC (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma, LLC117489663MANUFACTURE(77110-200)
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