EZ-448 ANTIBACTERIAL MOIST HAND (BENZALKONIUM CHLORIDE) SWAB [EZ PRODUCTS OF SOUTH FLORIDA, LLC]

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EZ-448 ANTIBACTERIAL MOIST HAND (BENZALKONIUM CHLORIDE) SWAB [EZ PRODUCTS OF SOUTH FLORIDA, LLC]
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NDC 69446-200-00
Set ID 664ab52d-60e3-a8c8-e053-2a91aa0a7c40
Category HUMAN OTC DRUG LABEL
Packager Ez Products Of South Florida, LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.11%

    Purpose

    Antiseptic

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Do not use 

    in the eyes.

    Do not flush.

    Discontinue use if

    irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

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

  • Directions

    • Open label, remove one wipe, and unfold.
    • Wet hands thoroughly with product and allow to dry without wiping. Do not flush.
  • Other information

    • Store below 95°F (35°C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Propylene Glycol, Phenoxythanol, Polyaminopropyl Biguanide, Lauryl Glucoside, Tetrasodium EDTA, 2-Broma-2-Nitropropane-1,3-Diol, Chamomilla Recutita Extract, Aloe Barbadensis Leaf Juice Powder, Citric Acid, Sodium Citrate

  • Package Labeling:

    LabelBox

  • INGREDIENTS AND APPEARANCE
    EZ-448 ANTIBACTERIAL MOIST HAND 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69446-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69446-200-0020 in 1 PACKAGE12/18/2017
    12.85 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/17/2017
    Labeler - Ez Products Of South Florida, LLC (113456060)
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