Label: BEXTERA HEALTH HAND SANITIZER- ethyl 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 7, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use • Hand sanitizer to help reduce bacteria on the skin

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

    Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Put enough product in your palm to cover hands and rub hands together briskly until dry

    • Children under 6 years old should be supervised when using this product

  • STORAGE AND HANDLING

    Other information • Store below 1100F (430C)

    • May discolor certain fabrics or surfaces

  • INACTIVE INGREDIENT

    Inactive ingredients  Water, methyl cellulose, tertiary butyl alcohol (denaturant), denatonium benzoate.

  • SPL UNCLASSIFIED SECTION

    ANTIBACTERIAL

    ANTIVIRAL

    KILLS MOST GERMS

    SOURCED FROM A GMP CERTIFIED FACILITY

    Manufactured in a FDA registered Facility

    MADE IN U.S.A

    *These statements have not been evaluated by the Food and Drug Administration.

    This product is not intended to diagnose, treat, cure, or prevent any disease.

    Distributed by: Bextra Nutrition®

    7955 Airport Pulling Road Suite 205

    Naples, FL 34109

    www.bexteranutrition.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    BEXTERA HEALTH HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77342-101
    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
    WATER (UNII: 059QF0KO0R)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77342-101-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/05/2020
    Labeler - Bextera Llc (117513250)
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