Label: ZYLAST XP ANTISEPTIC- benzethonium chloride lotion

  • 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 March 31, 2014

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  • Active Ingredients

    Benzethonium Chloride - 0.20%

  • Purpose

    Antiseptic

  • Uses

    • Handwash to decrease bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.
  • Warnings

    • For external use only.
    • Avoid contact with eyes. In case of eye contact, rinse thoroughly with water.
    • Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.  
    • If swallowed, immediately call Poison Control Center or doctor.
  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
  • Other Information

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

    Water, Alcohol Denat., Cetearyl Alcohol, Glycerin, Polyaminopropyl Biguanide, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Panthenol, Zinc Gluconate, Chlorhexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.

  • Active Ingrdients

    Benzethonium Chloride - 0.20%

  • Purpose

    Antiseptic

  • Uses

    • Handwash to decrease bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.
  • Warnings

    • For external use only.
    • Avoid contact with eyes. In case of eye contact, rinse thoroughly with water.
    • Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.  
    • If swallowed, immediately call Poison Control Center or doctor.
  • Keep out of reach of children.

     If swallowed, immediately call Poison Control Center or doctor.

  • Directions

    •  Wet hands thoroughly with product and allow to dry without wiping.
  • Other Information

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

    Water, Alcohol Denat., Cetearyl Alcohol, Glycerin, Polyaminopropyl Biguanide, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Panthenol, Zinc Gluconate, Chlorhexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.

  • Package/Label Principal Display Panel

    NDC 57702-465-14
    Zylast XP
    Extended Protection
    Broad Spectrum
    Antimicrobial
    Antiseptic
    1000mL (33.8oz)

    NDC 57702-465-14 Zylast XP Extended Protection Broad Spectrum Antimicrobial Antiseptic 1000mL (33.8oz)
  • Package/Label Principal Display Panel

    NDC 57702-465-04
    Zylast XP
    Extended Protection
    Broad Spectrum
    Antimicrobial
    Antiseptic
    8 fl oz. 236.6 mL

    NDC 57702-465-04 Zylast XP Extended Protection Broad Spectrum Antimicrobial Antiseptic 8 fl oz. 236.6 mL
  • Package/Label Principal Display Panel

    NDC 57702-465-01
    Zylast XP
    Extended Protection
    Broad Spectrum
    Antimicrobial
    Antiseptic
    2 fl oz 59.1 mL

    NDC 57702-465-01 Zylast XP Extended Protection Broad Spectrum Antimicrobial Antiseptic 2 fl oz 59.1 mL
  • INGREDIENTS AND APPEARANCE
    ZYLAST XP ANTISEPTIC 
    benzethonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57702-465
    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
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FARNESOL (UNII: EB41QIU6JL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57702-465-0159.1 mL in 1 BOTTLE
    2NDC:57702-465-04236.6 mL in 1 BOTTLE
    3NDC:57702-465-141000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/01/2011
    Labeler - Bocchi Laboratories Inc. (078376306)
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