Label: LIVEGREEN SPEARMINT ANTIBACTERIAL FOAMING HAND WASH- 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 1, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Use

    ■ For hand washing to decrease bacteria on the skin

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

    Do not use

    • in children less than 2 months of age
    • on open skin wound

    When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

  • Directions

    Apply a small amount to hands, lather, then rinse with warm water.

    Avoid contact with eyes

  • Other Information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIVEGREEN SPEARMINT ANTIBACTERIAL FOAMING HAND WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-406
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-406-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/31/2020
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-406)
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