Label: 5 SECONDS DISINFECTANT WIPES- benzalkonium chloride cloth

  • 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 16, 2020

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  • Active Ingredient

    BENZALKONIUM CHLORIDE 0.13% 

    Purpose

    Antibacterial

  • USES

    Decrease bacteria on skin

  • Warnings

    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 If irritation or rash appears and lasts.

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

  • Inactive ingredients

    Purified Water, Phenoxyethanol, Glycerin, Ethylhexylglycerin, DDAC, Propylene Glycol

  • PRINCIPAL DISPLAY PANEL

    lable image

  • INGREDIENTS AND APPEARANCE
    5 SECONDS DISINFECTANT WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77909-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77909-004-0110 in 1 BAG06/16/2020
    15.25 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:77909-004-0250 in 1 BAG06/16/2020
    25.25 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 finalpart333A06/16/2020
    Labeler - Zhejiang Huihao Daily Products Co.,Ltd (541292810)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Huihao Daily Products Co.,Ltd541292810manufacture(77909-004)
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