Label: ZYLAST ANTISEPTIC K- benzalkonium chloride lotion

  • NDC Code(s): 57362-468-00, 57362-468-03, 57362-468-04, 57362-468-05
  • Packager: Innovative Biodefense
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2023

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  • Active Ingredient

    Benzalkonium Chloride- 0.13%

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on 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 thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a poison control center right away.

  • Stop use and ask a doctor if

    Irritation or redness develops. Condition persists for more than 72 hours.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only with adult supervision.

  • Inactive Ingredient

    Water, Alcohol Denature, Cetearyl Alcohol, Glycerin,Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Panthenol, Zinc Gluconate, Chlorhexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.

  • Other Information

    Store at 20-25°C (68-77°F)

  • PRINCIPAL DISPLAY PANEL

    NDC 57362-468-04

    Zylast

    Broad Sprectrum

    Antimicrobial

    Antiseptic

    14.79 mL (0.5 fl. oz)

    0.5 Lotion K

    NDC 57362-468-00

    Zylast

    Broad Sprectrum

    Antimicrobial

    Antiseptic

    59.159 mL (2 fl. oz)

    2 oz Lotion K

    NDC 57362-468-03

    Zylast

    Broad Sprectrum

    Antimicrobial

    236.59 mL (8 fl. oz)

    8 oz Lotion K

    NDC 57362-468-05

    Zylast

    Broad Sprectrum

    Antimicrobial

    Antiseptic

    1000 mL (33.8 fl. oz)

    1000 mL lotion K

  • INGREDIENTS AND APPEARANCE
    ZYLAST ANTISEPTIC K 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57362-468
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57362-468-0414.8 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2020
    2NDC:57362-468-0059.1 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2020
    3NDC:57362-468-03236.6 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2020
    4NDC:57362-468-051000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/2020
    Labeler - Innovative Biodefense (078363903)
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