Label: 8.75OZ ANTIBACTERIAL FOAM HANDSOAP - GREEN TEA- 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 5, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13% , Antibacterial

  • Purpose

    Antibacterial, Hand SOAP

  • Use

    For handwashing to decrease bacteria on skin.

  • Warnings

    For external use only. Keep away from fire or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes. If contact with eyes occurs, rinse thoroughly with water.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    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 - Principal Display Panel

    259 ml labeler

  • INGREDIENTS AND APPEARANCE
    8.75OZ ANTIBACTERIAL FOAM HANDSOAP - GREEN TEA 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90114-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90114-251-01259 mL in 1 BOTTLE; Type 0: Not a Combination Product11/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/05/2020
    Labeler - Hero Brands, Inc. (117527162)
    Registrant - Hero Brands, Inc. (117527162)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zorin Pharmaceutical Technology (Hangzhou) Co Ltd.554529819manufacture(90114-251)
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