Label: ALL PURPOSE CLEANING AND SANITIZING WIPES- cleaning and sanitizing wipes 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 June 29, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Antiseptic

  • Uses

    Suitable for wiping hands, face, skin and other unbroken skin.

  • Warnings

    For external use only. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center. Do not use as baby wipes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • Directions

    Product is ready to use. Unfold the premoistened cloth and wipe down desired cleaning area.

  • Other Information

    Storage and Disposal: Do not leave container open during storage. No special handling required. Do not reuse wipe. Dispose of wipe in the trash. Then container cannot be reused.

  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, 2-Bromo-2-Nitropropane-1,3-Diol, Disodium EDTA, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    80 Wipes in a bottle, NDC: 81559-001-01

    80 Wipes Bottle Label

  • PRINCIPAL DISPLAY PANEL

    10 Wipes, NDC: 81559-001-02

    10 Wipes Label

  • PRINCIPAL DISPLAY PANEL

    20 Wipes, NDC: 81559-001-03

    20 Wipes Label

  • PRINCIPAL DISPLAY PANEL

    30 Wipes, NDC: 81559-001-04

    30 Wipes Label

  • PRINCIPAL DISPLAY PANEL

    80 Wipes, NDC: 81559-001-05

    80 Wipes Bag Label

  • INGREDIENTS AND APPEARANCE
    ALL PURPOSE CLEANING AND SANITIZING WIPES 
    cleaning and sanitizing wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81559-001
    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)  
    COCO/OLEAMIDOPROPYL BETAINE (UNII: 5M84PX7JN2)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81559-001-0180 in 1 BOTTLE02/20/2021
    10.13 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:81559-001-0210 in 1 BAG02/20/2021
    20.13 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:81559-001-0320 in 1 BAG02/20/2021
    30.13 g in 1 PATCH; Type 0: Not a Combination Product
    4NDC:81559-001-0430 in 1 BAG02/20/2021
    40.13 g in 1 PATCH; Type 0: Not a Combination Product
    5NDC:81559-001-0580 in 1 BAG02/20/2021
    50.13 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/20/2021
    Labeler - Globe Commercial Products Inc (201307684)
    Registrant - Globe Commercial Products Inc (201307684)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Lookon Commodity Co., Ltd.541760483manufacture(81559-001) , relabel(81559-001)
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