Label: LIVEGREEN EUCALYPTUS MINT ANTIBACTERIAL FOAMING HAND WASH- benzalkonium chloride solution

  • 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 June 30, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Use

    ■ To decrease bacteria on hands

  • WARNINGS

    For external use only

    Do not use if you are allergic to any ingredients listed

    Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

    Do not get into eyes. Rinse thoroughly with water if contact occurs

    keep out of reach of children

    Keep out of reach of children

  • Directions

    Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

  • Inactive ingredients

    Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Eucalyptus Globulus Leaf Extract, Mentha Arvensis
    Extract, Yellow 5, Blue 1

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIVEGREEN EUCALYPTUS MINT ANTIBACTERIAL FOAMING HAND WASH 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-233
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-233-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2020
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Chengda Industrial Co., Ltd540042034manufacture(50563-233)
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