Label: ZYLASTXP ANTISEPTIC FOAMING- benzethonium chloride soap

  • NDC Code(s): 57362-467-01, 57362-467-02
  • Packager: Innovative Biodefense
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2023

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  • Active Ingredients

    Benzethonium Chloride - 0.20%

  • Purpose

    Antiseptic

  • Uses

    • Handwash to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    • For external use only.
    • When using this product, do not use in or near eyes. In case of contact, rinse eyes throroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
  • Stop use and ask a doctor if

    Irritation or redness develops.

    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 and forearms. Apply one pump to hands and forearms thoroughly for 15 seconds or more. Rinse and repeat. For children under 6, use only with adult supervision.
  • Other Inforamtion

    • Store at 20-25°C (68-77°F) 
  • Inactive ingredients

    Alcohol Denatured, Aloe Barbadenis Lead Extract, Butylene Glycol, Cetrimonium Chloride, Citric Acid, Cocamidopropyl Betaiine, Farnesol, Fragrance, Glycerin, Lauramine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Polyaminopropyl Biguanide, Polyquaternium-10, PPG-12 Hydroxyethyl Cocamide, Water, Zinc Gluconate

  • Package/Label Principal Display Panel

    NDC 57362-467-01
    Zylast
    Extended Protection
    Broad Spectrum
    Antimicrobial
    Antiseptic

    Foaming Soap
    8.25 oz

    8.25 oz

  • Package/Label Principal Display Panel

    NDC 57362-467-02
    Zylast
    Extended Protection
    Broad Spectrum
    Antimicrobial
    Antiseptic

    Foaming Soap
    1000mL (33.8oz)

    1000mL

  • INGREDIENTS AND APPEARANCE
    ZYLASTXP ANTISEPTIC FOAMING 
    benzethonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57362-467
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FARNESOL (UNII: EB41QIU6JL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57362-467-01244 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2015
    2NDC:57362-467-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/06/2015
    Labeler - Innovative Biodefense (078363903)
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