Label: HAND WIPES- benzalkonium 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 September 4, 2020

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  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • 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, Alcohol, Cocamidopropyl Betaine, Phenoxyethanol, Propylene Glycol, Disodium EDTA, Fragrance, Butylene Glycol, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Origanum Vulgare Flower/Leaf/Stem Extract, Thymus Vulgaris (Thyme) Extract, Camellia Sinensis Leaf Extract

  • Principle Display Panel

    Fresh Scent

    Wet wiptes

    Antibacterial formula

    30 wipes

    pouch

  • INGREDIENTS AND APPEARANCE
    HAND WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-1888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    ROSEMARY (UNII: IJ67X351P9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    THYME (UNII: CW657OBU4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-1888-330 in 1 POUCH; Type 0: Not a Combination Product03/16/2020
    2NDC:67510-1888-224 in 1 PACKET; Type 0: Not a Combination Product09/01/2020
    3NDC:67510-1888-440 in 1 CANISTER; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/16/2020
    Labeler - Kareway Product, Inc. (121840057)
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