Label: MOONLITE ANTIBACTERIAL- benzalkonium chloride liquid

  • NDC Code(s): 50157-511-23
  • Packager: Brands International Corporation
  • 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 September 23, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antiseptique(skin)cleanser

  • INDICATIONS & USAGE

    Uses Effective in destorying(harmful) bacteria to provide antiseptic cleansing.

  • WARNINGS

    Warning For external use only

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • WHEN USING

    When using the product

    • avoid contact wiith eyes. If contact occurs rinse eye thoroughly with water
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Direction

    • Adults and children over 2 year
    • For occasional and personal domestic use
    • Supervise children when use this product
    • Lather in hands with water for at least 30 seconds 
    • Rinse well
  • OTHER SAFETY INFORMATION

    • Store below 110F(43)
    • May discolor certain fabrics or surfaces.
  • INACTIVE INGREDIENT

    Water,Lauramidopropylamine Oxide ( Triaminox LO ), Lauryl Glucoside, Citric Acid, PEG-150 distearate, Glycol Stearate, PEG-7 Glyceryl Cocoate,Cetrimonium Chloride, Tetrasodium EDTA,Isopropyl myristate, Aloe Leaf, Tocopheryl Acetate, Methylchloroisothiazolinone, Methylisothiazolinone,

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    MOONLITE ANTIBACTERIAL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    WATER (UNII: 059QF0KO0R)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-511-23236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2020
    Labeler - Brands International Corporation (243748238)
    Registrant - Brands International Corporation (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corporation243748238manufacture(50157-511)
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