Label: WIPE OUT ANTIBACTERIAL LIQUID HAND JUICY PEACH- benzalkonium chloride soap

  • 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 23, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride  0.13%

  • Purpose

    Antibacterial

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

  • WHEN USING

    When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop, condition persists 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

    • Wet hands 
    • Apply palmful to hands
    • Scrub thoroughly for at least 15 seconds
    • Rinse thoroughly and dry
  • Inactive ingredients

    Water, Cocamidopropyl dimethylamine oxide, Citric Acid, Fragrance, Kathon, Glycerin, Fatty acyl diethanol amine, Disodium EDTA, Hydroxyethyl Cellulose (250HHR), Red 7 (CI 16255), Yellow 5 (CI 19140)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WIPE OUT ANTIBACTERIAL LIQUID HAND JUICY PEACH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77878-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77878-031-01221 mL in 1 BOTTLE; Type 0: Not a Combination Product12/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/23/2020
    Labeler - TZUMI INNOVATIONS LLC (117426322)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aogrand International Trade Corporation421353092manufacture(77878-031)
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