DAWNMIST ANTIBACTERIAL (BENZALKONIUM CHLORIDE) GEL [DUKAL CORPORATION]

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DAWNMIST ANTIBACTERIAL (BENZALKONIUM CHLORIDE) GEL [DUKAL CORPORATION]
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NDC 65517-1022-1
Set ID 3abfd7f5-a7ea-4e7a-80c4-ba3fcb4cc6e3
Category HUMAN OTC DRUG LABEL
Packager Dukal Corporation
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hands only

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse eyes with water.

    Stop use and ask a doctor if

    • irritation and redness develops
    • condition persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, cetrimonium chloride, decyl glucoside, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 33, red 40, yellow 5

  • Principal Display Panel - DawnMist Handwashing Antibacterial Hand Soap Label

    ImageDawnMist®

    HANDWASHING

    Antibacterial



    Hand Soap

    LIGHT FRESH SCENT



    pH BALANCED

    DERMATOLOGIST TESTED

    8 FL OZ (236 mL)

  • INGREDIENTS AND APPEARANCE
    DAWNMIST ANTIBACTERIAL 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-1022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-1022-1236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/11/2018
    Labeler - Dukal Corporation (791014871)
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