Label: WET ONES ANTIBACTERIAL HAND WIPES TROPICAL SPLASH- benzalkonium chloride swab

  • NDC Code(s): 63354-989-15, 63354-989-24, 63354-989-40
  • 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 January 13, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial Agent

  • Use

    decreases bacteria on skin

  • Warnings

    For external use only

    Do not use

    if you are allergic to any of the ingredients

    When using this product

    do not get into eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash develops and continues for more than 72 hour

    Keep out of reach of children.

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

  • Directions

    adults and childre 2 years and over • apply to hands • allow skin to dry without wiping

    children under 2 years ask a doctor before use

  • Inactive Ingredients

    Water, Alcohol Denat., Phenoxyethanol, PEG-8 Dimethicone. Caprylyl Glycol, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Potassium Sorbate, Disodium EDTA, Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice

  • PDP

    Wet

    Ones®

    ANTIBACTERIAL

    HAND WIPES

    Tropical Splash

    Kills 99.99% of Germs

    Hypoallergenic Paraben Free

    Fresh, Clean Feel

    America's #1 Hand Wipe*

    63354-989-40

    63354-989-15-1

    63354-989-15-2

    63354-989-15-3

    63354-989-24-1

    63354-989-24-2

    63354-989-24-3

  • INGREDIENTS AND APPEARANCE
    WET ONES ANTIBACTERIAL HAND WIPES TROPICAL SPLASH 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-989
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-989-1520 in 1 POUCH; Type 0: Not a Combination Product09/26/2019
    2NDC:63354-989-2424 in 1 PACKET; Type 0: Not a Combination Product09/26/2019
    3NDC:63354-989-4040 in 1 CANISTER; Type 0: Not a Combination Product09/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/26/2019
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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