Label: DISINFECTING WIPES- benzalkonium chloride,didecyl dimethyl ammonium chloride cloth

  • NDC Code(s): 75328-501-01
  • Packager: CROWN (YANGZHOU) HEALTH & BEAUTY 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 November 12, 2020

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

  • SPL UNCLASSIFIED SECTION

    DISINFECTING WIPES

  • Active Ingredient(s)

    Benzalkonium Chloride 0.2%, w/w
    DiDecyl dimethyl ammonium chloride 0.2%, w/w

  • Purpose

    Antiseptic

  • Use

    DISINFECTING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Phenoxyethanol
    Ethylhexyl glycerin
    Propylene Glycol
    Glycerin
    Purified Water

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    DISINFECTING WIPES 
    benzalkonium chloride,didecyl dimethyl ammonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75328-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.2   in 100 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75328-501-0115 in 1 BAG; Type 0: Not a Combination Product11/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/13/2020
    Labeler - CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. (542978427)
    Establishment
    NameAddressID/FEIBusiness Operations
    CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.542978427manufacture(75328-501)