Label: FUBU ANTISEPTIC HAND SANITIZER WIPES- benzalkonium chloride cloth

  • 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 December 17, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

    Do not use

    in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists 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

    • wet hands thoroughly with product and allow to dry without wiping
  • Other information

    • Store at room temperature.
    • Keep lid tightly closed when not in use.
  • Inactive ingredients

    Benzoic Acid, C12-15 Pareth 12, Citric Acid, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Water.

  • Package Labeling:15 WIPES

    Bottle

  • Package Labeling:72 WIPES

    Bottle2

  • INGREDIENTS AND APPEARANCE
    FUBU ANTISEPTIC HAND SANITIZER WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81226-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81226-000-0115 in 1 POUCH01/01/2021
    11.8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:81226-000-0272 in 1 POUCH01/01/2021
    23.47 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2021
    Labeler - TITUS KOZMETIK ARGE SANAYI VE TICARET LIMITED SIRKETI (595832524)
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