Label: GOOD CLEAN SUDS ANTIBACTERIAL FOAM HAND GREEN TEA SCENTED- 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 November 20, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride ................. 0.13%

    Purpose

    Antibacterial

    USE

    For handwashing to decrease bacteria on skin.

  • Warnings

    For external use only.

    When using this product

    keep out of eyes, if contact with eyes occurs, rinse thoroughly with water.

    Stop use and ask a doctor

    if irritation and rash develops.

    Keep out of reach of children.

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

  • Directions

    • Wet hands
    • Apply foaming soap to hands and work into rich lather.
    • Rinse hands thoroughly.
  • Inactive ingredients

    Disodium Cocoamphodiacetate, Water, Glycerin, Citric Acid, EDTA-2Na, CAB-35, Fragrance

  • package

    label image

  • INGREDIENTS AND APPEARANCE
    GOOD CLEAN SUDS ANTIBACTERIAL FOAM HAND GREEN TEA SCENTED 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75183-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75183-104-01259 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/20/2020
    Labeler - Zorin Pharmaceutical Technology (Hangzhou) Co Ltd. (554529819)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zorin Pharmaceutical Technology (Hangzhou) Co Ltd.554529819manufacture(75183-104)