HAND SANITIZER (BENZALKONIUM CHLORIDE) LOTION [HUMPHREYLINE]

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HAND SANITIZER (BENZALKONIUM CHLORIDE) LOTION [HUMPHREYLINE]
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NDC 19392-500-02, 19392-500-03
Set ID d1045e66-e281-4127-a584-61949034b73c
Category HUMAN OTC DRUG LABEL
Packager Humphreyline
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    benzalkonium chloride (0.13%)

  • PURPOSE

    antimicrobial

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin

  • WARNINGS

    For external use only

    Do not use in or near the eyes

    Stop use and ask a doctor if irritation or rash appears and lasts

    Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product and allow to dry without wiping

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

  • INACTIVE INGREDIENT

    Water, cetearyl alcohol, petrolatum, behenamidopropyl dimethylamine lactate, lauryl laurate, glycerin, glycereth-2-cocoate, dimethicone, benzoic acid

  • PRINCIPAL DISPLAY PANEL

    frontpanel

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BEHENAMIDOPROPYL DIMETHYLAMINE BEHENATE (UNII: 96T33VV28E)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-500-0215 g in 1 BOTTLE, PLASTIC
    2NDC:19392-500-0330 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2014
    Labeler - Humphreyline (122539042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humphreyline122539042pack(19392-500)
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