Label: ANTIBACTERIAL 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 December 30, 2020

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  • Active ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antibacterial

  • Use

    decreases bacteria on skin

  • Warnings

    For external use only.
    Do not use
    over large areas of the body
    if you are allergic to any of the ingredients
    When using this product avoid contact with eyes.
    lf contact occurs, flush thoroughly with water.
    Stop use and ask a doctor if irritation or rash develops and
    continues for more than 72 hours.

    Keep out of reach of children

    if swallowed

    get medical help or contact a Poison Control Center right away.

  • Directions

    for adults and children of 2 years and over
    children under 2 years ask a doctor before use allow to dry without wiping

  • INACTIVE INGREDIENT

    Water, Glycerin, Phenoxyethanol, Polysorbate 20,Aloe Barbadensis
    Leaf Extract， Polyaminopropyl Biguanide, Disodium EDTA,
    Fragrance, 2-Bromo-2-Nitropropane-1,3-Diol,Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59575-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59575-800-0136 in 1 BAG12/30/2020
    120 in 1 PACKAGE
    178.3 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/30/2020
    Labeler - Hebei Yihoucheng Commodity Co.,Ltd. (529305333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hebei Yihoucheng Commodity Co.,Ltd.529305333manufacture(59575-800)
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