Label: WET ONES ANTIBACTERIAL NON PLASTIC HAND WIPES- benzalkonium chloride swab

  • NDC Code(s): 63354-909-20
  • Packager: Edgewell Personal Care Brands LLC
  • 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 September 27, 2022

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  • Active ingredient

    Benzalkonium Chloride 0.12%

  • Purpose

    Antimicrobial Agent

  • Uses

    Medicated skin cleanser • For personal hand hygiene to help prevent the spread of bacteria

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. If contact occurs, rinse with water

    Stop use and ask a doctor

    if irritation develops.

    Keep out of reach of children

    If swallowed, call a poison control center or get medical help right away.

  • Directions

    • For occasional and personal domestic use.
    • Supervise children when they use this product.
    • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Inactive ingredients

    Water, Alcohol Denat., Propylene Glycol,
    Phenoxyethanol, Caprylyl Glycol, Lauryl
    Glucoside, Citric Acid, Ethylhexylglycerin,
    Tetrasodium EDTA, Fragrance, Aloe
    Barbadensis Leaf Extract.

  • Questions?

    1-866-938-1117

  • PRINCIPAL DISPLAY PANEL

    Tough on Germs

    Gentle on Skin

    Wet

    Ones

    ANTIBACTERIAL

    NON PLASTIC HAND WIPES

    Plant Based

    Fibers

    KILLS 99.99% OF GERMS

    Hypoallergenic

    20

    wipes

    Do Not Flush

    label

  • INGREDIENTS AND APPEARANCE
    WET ONES ANTIBACTERIAL NON PLASTIC HAND WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-909
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-909-2020 g in 1 POUCH; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2023
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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