Label: WET WIPES- benzethonium chloride swab

  • 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 July 29, 2020

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  • Active Ingredients

    Benzethonium Chloride 0.3%

  • Purpose

    Antibacterial

  • Use

    decrease 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 throroughly 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

    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, Butylene Glycol, Alcohol, Hyaluronic Acid, Polysorbate 80, Sodium Lauryl Sulfate, Disodium Lareth Sulfosuccinate,

    Glycerin, Phytosqualane, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Cyclopia Intermedia Leaf Extract,

    Tocopheryl Acetate, Phenoxyethanol, Disodium EDTA, Fragrance

  • Principle Display Panel

    Fresh Scent

    Wet wiptes

    Antibacterial formula

    30 wipes

    wipes

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    benzethonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.3   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOPIA INTERMEDIA LEAF (UNII: 29UXG2GG8O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0888-330 in 1 POUCH; Type 0: Not a Combination Product06/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2015
    Labeler - Kareway Product, Inc. (121840057)
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