Label: CLEANSING TOWELETTE- benzalkonium chloride swab

  • 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 February 1, 2018

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  • Active Ingredients

    Benzalkonium Chloride  0.13%

    Purpose

    Antiseptic

  • Use

    Cleasing of face,hands and body without soap and water.Air dryies in seconds.

    Non-sterile solution

    Applicator is sterile if package is intact.

  • Warnings

    For external use only
    Flammable,keep away for fire or flame

    Do not use:

    * In large quantities
    * over large areas of the body
    * in eyes
    * over raw or blistered areas

    Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

  • Directions

    Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.
    Children under 2 years of age ; Consult a doctor

  • Inactive Ingredient

    5% v/v alcohol,Purified Water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    CLEANSING TOWELETTE 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72059-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72059-005-011 in 1 POUCH; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2018
    Labeler - Nantong Sirius Packing Products Co., Ltd. (546071515)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Sirius Packing Products Co., Ltd.546071515manufacture(72059-005)
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