Label: ZYLASTXP 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 August 26, 2021

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  • ACTIVE INGREDIENT

    Benzethonium Chloride - 0.2%

  • PURPOSE

    Antiseptic

  • ASK DOCTOR

    Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, immediately call Poison Control Center of doctor.

  • DOSAGE & ADMINISTRATION

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

  • WARNINGS

    For external use only. Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water. Discontinue use if irriation and redness develops. Consult a doctor if condition persists for more than 72 hours.

  • INACTIVE INGREDIENT

    Water, Alcohol Denat., Cetearly Alcohol, Glycerin, Polyaminopropyl Biguanide, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Pantenol, Zinc Gluconate, Chlohexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.

  • INDICATIONS & USAGE

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

  • PRINCIPAL DISPLAY PANEL

    NDC 57362-464-00

    Zylast Antiseptic Lotion 2oz

    Broad Spectrum

    Antimicrobial

    2 oz. Lotion

  • INGREDIENTS AND APPEARANCE
    ZYLASTXP ANTISEPTIC 
    benzethonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57362-464
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE192.3 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 39.82 mL  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57362-464-00192.3 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/24/2015
    Labeler - Innovative BioDefense (078363903)
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