Label: ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

  • NDC Code(s): 77465-002-02
  • Packager: Zhejiang Youquan Care Products 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 15, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.13%.

    Purpose

    Antibacterial

  • USE

    decreases bacteria on skin

  • Warning

    For external use only
    Do not use if you are allergic to any ingredients When using this product do not get into your eyes. lf contact occurs, rinse thoroughly with water.
    Use of this product by children should be supervised by an adult.
    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

    Keep this out of reach of children.f swallowed, get medical help
    or contact a Poison Control Center immediately.

  • Directions

    adults and children 2 years and over
    ·Apply to hands
    ·Allow to dry without wiping
    children under 2 years
    ask a doctor before use

  • Inactive ingredients

    Water, Phenoxyethanol, Propylene Glycol, Glycerin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77465-002
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77465-002-0280 in 1 POUCH01/25/2021
    1252 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/25/2021
    Labeler - Zhejiang Youquan Care Products Technology Co., Ltd. (421318425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Youquan Care Products Technology Co., Ltd.421318425manufacture(77465-002)
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