Label: CITRUS ANTIBACTERIAL- benzalkonium chloride soap

  • 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 September 1, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only

  • WHEN USING

    When using this product avoid contact with eyes. in case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Pump into hands, wet as needed.
    • Lather for at least 15 seconds
    • Rinse and dry thoroughly.
  • Inactive ingredients

    Centrimonium Chloride, Cocamide MEA, Cocamidopropylamine Oxide, Fragrance, Glycerin, Lauramine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Red 4, Yellow 5, Water

  • PRINCIPAL DISPLAY PANEL

    Vish Antibacterial Soap

    Citrus Scented

    10 fl oz 300 ml

    Front Panel

  • INGREDIENTS AND APPEARANCE
    CITRUS ANTIBACTERIAL 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62685-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1755 g  in 135 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62685-121-01135 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    2NDC:62685-121-02225 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - Tropical Degil Cosmetics Industries LTD (600437230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Degil Cosmetics Industries LTD600437230manufacture(62685-121)
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