Label: HAND SANITIZING WIPES- benzalkonium chloride cloth

  • NDC Code(s): 78028-001-01
  • Packager: Dalian Daxin Nonwoven Technology 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 January 14, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.3%

    Purpose

    Antibacterial

  • USE

    For hand washing to decrease bacteria on the skin.
    Recommended for repeated use.

  • Warning

    For external use only. Do not use if you are allergic to
    any of the ingredients.

    Keep out of reach of children.

  • Directions

    Directions● Adults and children 2 yrs and over,
    apply to hands and allow skin to dry without wiping.
    ●Children under 2, ask doctor before use.

  • Inactive ingredients

    Water, Phenoxyethanol, Sodium
    benzoate, Propylene glycol, Aloe barbadensis leaf juice, PEG-8
    dimethicone, Benzethonium chloride, Disodium edta, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78028-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78028-001-0130 in 1 BAG05/20/2020
    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 finalpart333A05/18/2020
    Labeler - Dalian Daxin Nonwoven Technology Co., Ltd. (415363991)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Daxin Nonwoven Technology Co., Ltd. 415363991manufacture(78028-001)
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