Label: REFILL BUNDLE 7 LARGE OFFICE- benzalkonium chloride kit

  • NDC Code(s): 49687-0011-1, 49687-0029-0
  • Packager: CMC Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Antiseptic Towelette 10 count 49687-0011-0 DRUG FACTS

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

    Purpose:

    First Aid Antiseptic

  • Use:

    For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

  • Warnings:

    For external use only.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

    Do not use:

    In the eyes, or over large areas of the body.

  • Directions:

    Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

  • Inactive ingredient:

    Purified water.

  • Package Labeling:

    Kit3

  • Package Labeling:

    Label1

  • INGREDIENTS AND APPEARANCE
    REFILL BUNDLE 7 LARGE OFFICE 
    benzalkonium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0029
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0029-01 in 1 KIT02/13/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 PATCH 9 g
    Part 1 of 1
    ANTISEPTIC TOWELETTES 
    benzalkonium chloride cloth
    Product Information
    Item Code (Source)NDC:49687-0011
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0011-110 in 1 BOX
    10.9 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 DrugM00302/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/13/2018
    Labeler - CMC Group, Inc. (117201448)
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