Label: B-PURE CITRUS SCENTED HAND SANITIZER- alcohol liquid

  • NDC Code(s): 80684-096-00
  • Packager: Fourstar Group USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol, 70% v/v

    Purpose

    Antimicrobial

  • Uses

    hand sanitizer to help reduce bacteria on skin

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    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, excessive redness or rash develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Spray into hands and rub together briskly until dry.

  • Other information

    Store below 110°F (43°C)

  • Inactive ingredients

    Water, glycerin, fragrance, denatonium benzoate, citrus reticulata (tangerine) peel extract

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    B-PURE CITRUS SCENTED HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-096
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    TANGERINE PEEL (UNII: JU3D414057)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-096-0059 mL in 1 BOTTLE; Type 0: Not a Combination Product11/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/25/2023
    Labeler - Fourstar Group USA, Inc. (140099503)
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