Label: ZAZ ANTISEPTIC HAND- 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 May 9, 2022

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  • Active ingredient

    Benzalkonium chloride 0.1%

  • Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on the skin

  • Warnings

      For external use only

    Do not use in eyes

      Stop use and ask a doctor if

    • Irritation and redness develop
    • Condition persist for more than 72 hours

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

  • KEEP OUT OF REACH OF CHILDREN

  • Direction

    Wet hands and forearms. Apply to hands and forearms. Scrub thoroughly for 30-60 seconds. Rinse and repeat.

  • Inactive ingredients

    Fragrance, gliceryn, sodium cocoate, sodium tallowate, titanium dioxide, colors.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ZAZ ANTISEPTIC HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82726-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82726-001-01125 g in 1 PACKAGE; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2022
    Labeler - INDUSTRIAL LA FAMA SA DE CV (823760264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Industrial La Fama, S.A. de C.V.823760264manufacture(82726-001)
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