Label: ANTIBACTERIAL LIQUID HAND- benzalkonium chloride liquid

  • NDC Code(s): 50241-317-01, 50241-317-02, 50241-317-03
  • Packager: Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated December 20, 2023

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  • ACTIVE INGREDIENT

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

  • Purpose

    Antiseptic

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

  • When Using this Product

    Avoid contact with the eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops

    or if condition persist for more than 72 hours.

  • Keep out of reach of children.

    If swallowed, get medical help

    or contact Posion Control Center right away.

  • Directions

    -Pump into hands, wet as needed.

    -Lather skin Vigorously for at least 15 seconds.

    -Wash skin, rinse thoroughly and dry.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Caprylyl/Capryl Glucoside, Citric Acid, Cocamide MIPA, Cocamidopropyl Betaine, Fragrance, Glycerin, Lauryl Polyglucose, Magnesium Nitrate, Maltodextrin, Methylchloroisothiazolinone, Methylisothiazolinone, PEG 150 Distearate, FD&C Red #40, Tetrasodium EDTA, Water, FD&C Yellow #5

  • Antibacterial Liquid Hand Soap

    image description
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL LIQUID HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50241-317
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50241-317-021 in 1 BOX04/15/2018
    1NDC:50241-317-013.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50241-317-03209.75 kg in 1 DRUM; Type 0: Not a Combination Product04/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/15/2018
    Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(50241-317) , api manufacture(50241-317) , pack(50241-317)
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