Label: ANTISEPTIC TOWELETTE- benzalkonium chloride liquid

  • NDC Code(s): 0498-0501-00, 0498-0501-34, 0498-0501-37
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 12, 2024

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  • Active ingredient

    Benzalkonium chloride 0.13% w/v

  • Purpose

    First aid antiseptic

  • Uses

    Antiseptic cleansing of face, hands, and body without soap and water

  • Warnings

    For external use only

    Do not use

    • in the eyes or over large areas of the body
    • on mucous membranes
    • on irritated skin
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
    • longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • if irritation, redness or other symptoms develop
    • the condition persists or gets worse

    Keep out of reach of children

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

  • Directions

    • tear open packet and use as a washcloth
  • Other information

    • store at room temperature 15 0 to 30 0C (59 0 - 86 0F)
    • do not reuse towelette
  • Inactive ingredients

    water

  • Questions

    1-800-430-5490

  • Principal Display Panel

    Antiseptic Towelettes

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0501-3410 in 1 BOX, UNIT-DOSE12/21/2017
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-0501-376 in 1 BOX, UNIT-DOSE12/21/2017
    21.4 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/21/2017
    Labeler - Honeywell Safety Products USA, Inc (118768815)
    Registrant - Honeywell Safety Products USA, Inc (118768815)
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