Label: FITEBAC HAND SANITIZER- benzalkonium chloride 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 December 26, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on the skin
  • Warnings

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

  • Directions

    • Use only a small, pea-sized amount as needed, which is enough to cover both your hands.
    • Rub thoroughly over all surfaces of both hands
  • STORAGE AND HANDLING

    • Not intended to provide ongoing protection against new germ exposure
  • Inactive ingredients

    Cyclopentasiloxane, Dimethicone Crosspolymer, PPG-3 Benzyl Ether Ethylhexanoate

  • Questions, comments, side effects or reordering

    770-218-6221

  • SPL UNCLASSIFIED SECTION

    Distributed by FiteBac SkinCare, LLC, Marietta, Georgia 30064

  • PRINCIPAL DISPLAY PANEL

    Fitebac LitreFitebac tubeTube Display

  • INGREDIENTS AND APPEARANCE
    FITEBAC HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13136-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13136-002-0185 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    2NDC:13136-002-021000 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2019
    Labeler - FiteBac SkinCare, LLC (969593313)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Laboratories LLC016754201manufacture(13136-002)
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