Label: EVERGREEN FRESH LEMON SCENTED ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid

  • 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 August 12, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses • For handwashing to decrease bacteria on the skin

  • WARNINGS

    Warnings For external use only

    When using this product • Avoid contact with eyes. In case of eye contact, flush with water.

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

    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 vigorously for at least 15 seconds

    • Wash skin, rinse thoroughly and dry

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Cocamide MIPA, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Fragrance, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, CI 15985 (Yellow 6), CI 19140 (Yellow 5)

  • SPL UNCLASSIFIED SECTION

    BEST WAY TO GET RID OF GERMS

    Imported By:

    Evergreen USA LLC

    Hoboken, NJ 07030

    www.egreenusa.com

    PRODUCT OF TURKEY

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    EVERGREEN FRESH LEMON SCENTED ANTIBACTERIAL HANDSOAP 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74600-500
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74600-500-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - GENC GIDA KOZMETIK VE KIMYASAL URUNLER SANAYI VE TICARET LIMITED SIRKETI (356827969)
    Establishment
    NameAddressID/FEIBusiness Operations
    GENC GIDA KOZMETIK VE KIMYASAL URUNLER SANAYI VE TICARET LIMITED SIRKETI356827969manufacture(74600-500)