Label: PREMIUM NATURE ANTIBACTERIAL WIPES- benzalkonium chloride swab

  • NDC Code(s): 77267-008-01
  • Packager: Ningbo Riway Daily Commodity Co., Ltd.
  • 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 15, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • USE

    it is a violation of federal law to use this product in a manner inconsistent with its labeling.

    Wipe surface clean; use enough wipes for treated surface to remain visibly wet for few seconds.

    Let surface dry. For highly soiled surfaces, clean excess dirt first. Children under 6 years of age should be supervised by an adult when using this product.

  • Warning

    For external use only. Flammable. Keep away from heat or flame.

    HAZARDS TO HUMANS AND ANIMALS

    CAUTION:

    Cause moderote eye irritation, avoid contact with eyes and clothing. Wash thoroughly with soap and water after handling and before using tobacco, eating, drinking, or chewing gum.

    FIRST AID

    If in eyes: Hold eye open and rinse slowly with water for 15-20 minutes。 Remove contact lenses, if present, after first 5 inutes, then continue rinsing eye.

    When using this product: Avoid contact with face, eyes, nd broken skin. In case of contact, rinse thoroughly with plenty of water. Contact a Poison Control Center or Doctor for treatment advise.

    Do not use as diaper wipe. This product is not for use on dishes, glassware or untensils.

    Stop using and ask a doctor if irritation or redness develops.

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

  • Directions

    wipe surface clean.

  • Inactive ingredients

    Water, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    PREMIUM NATURE ANTIBACTERIAL WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77267-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77267-008-0170 in 1 BAG06/15/2020
    14 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - Ningbo Riway Daily Commodity Co., Ltd. (540997562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Riway Daily Commodity Co., Ltd.540997562manufacture(77267-008)