Label: NUVOMED ANTIBACTERIAL WET WIPES- benzalkonium chloride swab

  • NDC Code(s): 77435-004-01
  • Packager: HAINING LILY CLEANING 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 May 28, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.3% 

    Purpose

    Antiseptic

  • USE

    • For hand -washing to decrease bacteria on the skin when water is not available
  • Warning

    • Flammable, keep away from fire or flame. 
    • For external use only.

     When using this product

    • do not get in eyes 
    • do ot use on open or broken skin
    • if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor

    • if irritation and redness develops.

    Other Information：

    • Do not store above -20℃ to 30℃, away from sunlight

    If swallowed, get medical help or contact Poison Control Center right away

  • Directions

    • Wet hands thoroughly with product and allow to dry 20-30 seconds, do not dry or wipe when finished
  • Inactive ingredients

    Water, Propylene Glycol, Didecyldimonium Chloride, Phenoxyethanol, Chlorphenesin

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    NUVOMED ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77435-004
    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)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77435-004-0175 in 1 CANISTER05/28/2020
    13.15 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 finalpart333A05/28/2020
    Labeler - HAINING LILY CLEANING PRODUCTS CO., LTD (654463293)
    Establishment
    NameAddressID/FEIBusiness Operations
    HAINING LILY CLEANING PRODUCTS CO., LTD654463293manufacture(77435-004)
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