WIPE N GO (BENZALKONIUM CHLORIDE) SWAB [CANADIA USA CORPORATION]

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WIPE N GO (BENZALKONIUM CHLORIDE) SWAB [CANADIA USA CORPORATION]
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NDC 69538-200-01, 69538-200-02, 69538-200-03, 69538-200-04
Set ID 0b83a494-5224-41df-9559-20af6faa5a46
Category HUMAN OTC DRUG LABEL
Packager CANADIA USA CORPORATION
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient

    Benzalkonium Chloride, 0.1%

  • Purpose

    Antibacterial


  • Uses

    Antibacterial wipes for the skin.


  • Warnings

    For external use only.


    Do not use

    over large areas of the body if you are allergic to any of the ingredients.


    When using this product

    do not get into eyes, if contact occurs, rinse thoroughly with water.


    Stop use and ask a doctor if

    irritation or rash develops and continues for more than 24 hours.


    Keep out of reach of children

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


  • Directions:

    For adults and children of 2 years and over, use on hands and face to clean and refresh, allow skin to air dry.

    For children under 2 years, ask a doctor before use.


  • SPL UNCLASSIFIED SECTION


  • Inactive ingredients:

    Water, Disodium EDTA, Phenoxyethanol, Glycine, Polysorbate 20, Glycerin, Fragrance, Polyaminopropyl Biguanide, Sodium Citrate


  • Principal Display Panel

    wipe n' go

    Antibacterial HAND WIPES

    Made in China

    Distributed by: Canadia USA Corporation.



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  • INGREDIENTS AND APPEARANCE
    WIPE N GO 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69538-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCINE (UNII: TE7660XO1C)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69538-200-0124 in 1 BOX
    110 in 1 PACKAGE
    13 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69538-200-024 in 1 BOX
    210 in 1 CARTON
    210 in 1 PACKAGE
    23 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:69538-200-038 in 1 BOX
    310 in 1 CARTON
    310 in 1 PACKAGE
    33 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:69538-200-0412 in 1 BOX
    410 in 1 CARTON
    410 in 1 PACKAGE
    43 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/2015
    Labeler - CANADIA USA CORPORATION (012119600)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nox-Bellcow (Zhongshan) Nonwo ven Chemical Ltd528103343manufacture(69538-200)
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