Label: ANTIBACTERIAL WET WIPES- benzalkonium chloride swab 

  • Label RSS
  • NDC Code(s): 57817-100-01, 57817-100-02, 57817-100-03, 57817-100-04, view more
    57817-100-05, 57817-100-06, 57817-100-07, 57817-100-08, 57817-100-09, 57817-100-10, 57817-100-11, 57817-100-12, 57817-100-13, 57817-100-14, 57817-100-15, 57817-100-16, 57817-100-17, 57817-100-18, 57817-100-19, 57817-100-20, 57817-100-21, 57817-100-22, 57817-100-23, 57817-100-24, 57817-100-25, 57817-100-26, 57817-100-27, 57817-100-28, 57817-100-29, 57817-100-30, 57817-100-31, 57817-100-32, 57817-100-33, 57817-100-34, 57817-100-35, 57817-100-36, 57817-100-37, 57817-100-38, 57817-100-39, 57817-100-40, 57817-100-41, 57817-100-42, 57817-100-43, 57817-100-44, 57817-100-45, 57817-100-46, 57817-100-47, 57817-100-48, 57817-100-49, 57817-100-50, 57817-100-51, 57817-100-52, 57817-100-53, 57817-100-54, 57817-100-55, 57817-100-56, 57817-100-57, 57817-100-58, 57817-100-59, 57817-100-60, 57817-100-61, 57817-100-62, 57817-100-63, 57817-100-64, 57817-100-65, 57817-100-66
  • Packager: Hangzhou Haorun Technology CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • Active Ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antibacterial

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  • Use

    for hand washing to decrease bacteria on skin

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  • WARNINGS

    For External use only.
    Do not use if you are allergic to any of the ingredients.
    When using this product Do not get into eyes,if contact occurs ,rinse throughly with water.
    Discontinue use if irritation or redness develops if condition persists for more than 72 hours consults a physician.

    keep out of reach of children

    keep out of reach of children unless under adult supervision .if seallowed ,get medical help or contact a Poison Control Center immediately.

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  • Directions

    Thoroughly wipe hands or face with wipe,Discard in trash receptacle;do not flush.Be sure to reseal label complete to retain moisture

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  • Inactive ingredients

    WATER PROPYLENE GLYCOL OCTHILINONE .ALPHA.-TOCOPHEROL

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57817-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 0.13 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PROPYLENE GLYCOL  
    OCTHILINONE  
    .ALPHA.-TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57817-100-01 1 in 1 BOTTLE
    1 10 g in 1 POUCH
    2 NDC:57817-100-02 2 in 1 BOTTLE
    2 8 g in 1 POUCH
    3 NDC:57817-100-03 3 in 1 BOTTLE
    3 6 g in 1 POUCH
    4 NDC:57817-100-04 4 in 1 BOTTLE
    4 5 g in 1 POUCH
    5 NDC:57817-100-05 5 in 1 BOTTLE
    5 5 g in 1 POUCH
    6 NDC:57817-100-06 6 in 1 BOTTLE
    6 5 g in 1 POUCH
    7 NDC:57817-100-07 7 in 1 BOTTLE
    7 5 g in 1 POUCH
    8 NDC:57817-100-08 8 in 1 BOTTLE
    8 5 g in 1 POUCH
    9 NDC:57817-100-09 9 in 1 BOTTLE
    9 5 g in 1 POUCH
    10 NDC:57817-100-10 10 in 1 BOTTLE
    10 3.5 g in 1 POUCH
    11 NDC:57817-100-11 12 in 1 BOTTLE
    11 3.5 g in 1 POUCH
    12 NDC:57817-100-12 15 in 1 BOTTLE
    12 3 g in 1 POUCH
    13 NDC:57817-100-13 18 in 1 BOTTLE
    13 3 g in 1 POUCH
    14 NDC:57817-100-14 20 in 1 BOTTLE
    14 3 g in 1 POUCH
    15 NDC:57817-100-15 25 in 1 BOTTLE
    15 3 g in 1 POUCH
    16 NDC:57817-100-16 30 in 1 BOTTLE
    16 2.5 g in 1 POUCH
    17 NDC:57817-100-17 35 in 1 BOTTLE
    17 2.5 g in 1 POUCH
    18 NDC:57817-100-18 40 in 1 BOTTLE
    18 2.5 g in 1 POUCH
    19 NDC:57817-100-19 45 in 1 BOTTLE
    19 2.5 g in 1 POUCH
    20 NDC:57817-100-20 50 in 1 BOTTLE
    20 2.5 g in 1 POUCH
    21 NDC:57817-100-21 60 in 1 BOTTLE
    21 2.5 g in 1 POUCH
    22 NDC:57817-100-22 72 in 1 BOTTLE
    22 2.5 g in 1 POUCH
    23 NDC:57817-100-23 80 in 1 BOTTLE
    23 2.5 g in 1 POUCH
    24 NDC:57817-100-24 90 in 1 BOTTLE
    24 2.5 g in 1 POUCH
    25 NDC:57817-100-25 100 in 1 BOTTLE
    25 2.5 g in 1 POUCH
    26 NDC:57817-100-26 110 in 1 BOTTLE
    26 2.5 g in 1 POUCH
    27 NDC:57817-100-27 120 in 1 BOTTLE
    27 2.5 g in 1 POUCH
    28 NDC:57817-100-28 150 in 1 BOTTLE
    28 2.5 g in 1 POUCH
    29 NDC:57817-100-29 180 in 1 BOTTLE
    29 2.5 g in 1 POUCH
    30 NDC:57817-100-30 200 in 1 BOTTLE
    30 2.5 g in 1 POUCH
    31 NDC:57817-100-31 250 in 1 BOTTLE
    31 2.5 g in 1 POUCH
    32 NDC:57817-100-32 300 in 1 BOTTLE
    32 2.5 g in 1 POUCH
    33 NDC:57817-100-33 400 in 1 BOTTLE
    33 2.5 g in 1 POUCH
    34 NDC:57817-100-34 1 in 1 PACKAGE
    34 3 g in 1 POUCH
    35 NDC:57817-100-35 2 in 1 PACKAGE
    35 3 g in 1 POUCH
    36 NDC:57817-100-36 3 in 1 PACKAGE
    36 3 g in 1 POUCH
    37 NDC:57817-100-37 4 in 1 PACKAGE
    37 3 g in 1 POUCH
    38 NDC:57817-100-38 5 in 1 PACKAGE
    38 3 g in 1 POUCH
    39 NDC:57817-100-39 6 in 1 PACKAGE
    39 3.5 g in 1 POUCH
    40 NDC:57817-100-40 7 in 1 PACKAGE
    40 3.5 g in 1 POUCH
    41 NDC:57817-100-41 8 in 1 PACKAGE
    41 3.5 g in 1 POUCH
    42 NDC:57817-100-42 9 in 1 PACKAGE
    42 3.5 g in 1 POUCH
    43 NDC:57817-100-43 10 in 1 PACKAGE
    43 4 g in 1 POUCH
    44 NDC:57817-100-44 12 in 1 PACKAGE
    44 4 g in 1 POUCH
    45 NDC:57817-100-45 15 in 1 PACKAGE
    45 4 g in 1 POUCH
    46 NDC:57817-100-46 18 in 1 PACKAGE
    46 4 g in 1 POUCH
    47 NDC:57817-100-47 20 in 1 PACKAGE
    47 4 g in 1 POUCH
    48 NDC:57817-100-48 25 in 1 PACKAGE
    48 4 g in 1 POUCH
    49 NDC:57817-100-49 30 in 1 PACKAGE
    49 4 g in 1 POUCH
    50 NDC:57817-100-50 35 in 1 PACKAGE
    50 4 g in 1 POUCH
    51 NDC:57817-100-51 40 in 1 PACKAGE
    51 4 g in 1 POUCH
    52 NDC:57817-100-52 45 in 1 PACKAGE
    52 4 g in 1 POUCH
    53 NDC:57817-100-53 50 in 1 PACKAGE
    53 4 g in 1 POUCH
    54 NDC:57817-100-54 60 in 1 PACKAGE
    54 4 g in 1 POUCH
    55 NDC:57817-100-55 72 in 1 PACKAGE
    55 4 g in 1 POUCH
    56 NDC:57817-100-56 80 in 1 PACKAGE
    56 4 g in 1 POUCH
    57 NDC:57817-100-57 90 in 1 PACKAGE
    57 4 g in 1 POUCH
    58 NDC:57817-100-58 100 in 1 PACKAGE
    58 4 g in 1 POUCH
    59 NDC:57817-100-59 110 in 1 PACKAGE
    59 4 g in 1 POUCH
    60 NDC:57817-100-60 120 in 1 PACKAGE
    60 4 g in 1 POUCH
    61 NDC:57817-100-61 150 in 1 PACKAGE
    61 4 g in 1 POUCH
    62 NDC:57817-100-62 180 in 1 PACKAGE
    62 4 g in 1 POUCH
    63 NDC:57817-100-63 200 in 1 PACKAGE
    63 4 g in 1 POUCH
    64 NDC:57817-100-64 250 in 1 PACKAGE
    64 4 g in 1 POUCH
    65 NDC:57817-100-65 350 in 1 PACKAGE
    65 4 g in 1 POUCH
    66 NDC:57817-100-66 400 in 1 PACKAGE
    66 4 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/29/2013
    Labeler - Hangzhou Haorun Technology CO.,LTD. (421308583)
    Establishment
    Name Address ID/FEI Business Operations
    Hangzhou Haorun Technology CO.,LTD. 421308583 manufacture(57817-100)
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