ZYLAST ANTISEPTIC (BENZALKONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]

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ZYLAST ANTISEPTIC (BENZALKONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]
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NDC 57362-468-00, 57362-468-03, 57362-468-05
Set ID 84766b3b-915c-b604-e053-2a91aa0a672c
Category HUMAN OTC DRUG LABEL
Packager Innovative Biodefense
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active Ingredient

    Benzalkonium Chloride- 0.13%

  • Purpose

    Antiseptic

  • Uses

    Hand wash to decrease bacteria on the skin that potentailly can cause disease. Recommended for repeated use. First aid to help prevent the risk of bacteria contamination in minor cuts, scrapes, and burns.

  • Warnings

    For exrenal use only. Avoid contact with eye. In case of eye contact, rinse eyes thoroughly with water. Discontinue use if irritation and redness develops. Consult a doctor if conidtion persists for more than 72 hours. If swallowed, immeditely 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.

  • Inactive Ingredient

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

  • PRINCIPAL DISPLAY PANEL

    NDC 57362-468-00

    Zylast XP

    Broad Spectrum

    Antimicrobial

    Antiseptic

    59.1 mL (2 fl oz)

    2oz Antiseptic Lotion K

  • PRINCIPAL DISPLAY PANEL

    NDC 57362-468-03

    Zylast XP

    Broad Sprectrum

    Antimicrobial

    Antiseptic

    236.6 mL (8 fl. oz)

    Antiseptic Lotion K 8 oz

  • PRINCIPAL DISPLAY PANEL

    NDC 57362-468-05

    Zylast XP

    Broad Spectrum

    Antimicrobial

    Antiseptic

    1000 mL (33.8 fl. oz)

    Antiseptic Lotion K 1000 mL

  • INGREDIENTS AND APPEARANCE
    ZYLAST ANTISEPTIC 
    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 CHLORIDE296 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57362-468-05296 mg in 1 BOTTLE; Type 0: Not a Combination Product01/15/2019
    2NDC:57362-468-03296 mg in 1 BOTTLE; Type 0: Not a Combination Product01/15/2019
    3NDC:57362-468-00296 mg in 1 BOTTLE; Type 0: Not a Combination Product01/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/15/2019
    Labeler - Innovative Biodefense (078363903)
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