Label: ANTIBACTERIAL WIPES- didecyl dimethyl ammonium chloride, benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL

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 February 3, 2021

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  • Active Ingredient(s)

    Didecyl Dimethyl Ammonium Chloride 0.5%

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

    Antibacterial

  • Uses

    For hand sanitizing to decrease bacteria on the skin.

  • Do not use

    • In the eyes
    • If you are allergic to any of the ingredients.
  • WHEN USING

    When using this product if eye contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Storage. Store at room temperature.
    • Dispensing. Peel resealable label back slowly. Reseal after use to avoid wipes drying out.
    • Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping. To ensure best quality, use within 30 days of opening.
    • Disposal. Dispose of used wipes in trash receptacle. Do not flush.
  • Inactive ingredients

    Ion Exchanged Water (Food Grade), Propan-2-ol, Bronopol, Natural Soybean Amino Acid (Food Grade), Phenoxyethanol.

  • WARNINGS

  • Package Label - Principal Display Panel

    40 Wipes

    PDP

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    didecyl dimethyl ammonium chloride, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80202-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.008 g  in 8.1 g
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.04 g  in 8.1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMINO ACIDS, SOY (UNII: NWB9514AZM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80202-311-40324 g in 1 BAG; Type 0: Not a Combination Product02/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/03/2021
    Labeler - Abby&Finn LLC (107538616)
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