Label: KEEP CLEAN SURFACE CLEANING WIPES- benzalkonium chloride and didecyldimonium chloride swab

  • NDC Code(s): 78823-002-01
  • Packager: Zhejiang Ruolin Hygienic Products 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 9, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Didecyldimonium Chloride 0.2%

    Purpose

    Antimicrobial

  • USE

    Wipes for surface cleaning

  • Warning

    • For external use only.
    • When using this product, Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    • Stop use and ask a doctor, f irritaion and rash appears and lasts.

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

  • Directions

    • Apply wipe to surface and allow to dry
    • Discard wipes in trash receptacle after use. Do not flush.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    Water, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    KEEP CLEAN SURFACE CLEANING WIPES 
    benzalkonium chloride and didecyldimonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78823-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.10   in 100 g
    didecyldimonium chloride (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) didecyldimonium chloride0.20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78823-002-0170 in 1 BAG06/09/2020
    14.05 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 finalpart333A05/06/2020
    Labeler - Zhejiang Ruolin Hygienic Products Co., Ltd. (415426870)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruolin Hygienic Products Co., Ltd.415426870manufacture(78823-002)
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