Label: ANTISEPTIC TOWELETTE- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 18, 2017

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  • ACTIVE INGREDIENT

    Active ingredient

    Purpose - Benzalkonium Chloride 0.13% v/v....................Antiseptic

  • PURPOSE

    Uses

    For handwashing to decrease bacteria on the skin

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    In the eyes. If this happens, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water

  • DOSAGE & ADMINISTRATION

    Antiseptic Towelette

    Sting-free

  • PRINCIPAL DISPLAY PANEL

    BZK

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71310-002
    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:71310-002-011.6 g in 1 POUCH; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2017
    Labeler - Taizhou Kangping Medical Science And Technology Co., Ltd (543429840)
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