Label: ZYLAST ANTISEPTIC S- ethyl alcohol liquid

  • NDC Code(s): 57362-466-16, 57362-466-17, 57362-466-41
  • Packager: Innovative BioDefense
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2023

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  • ACTIVE INGREDIENT

    Ethyl Alcohol - 76%

  • PURPOSE

    Antiseptic

  • Uses

    • To decrease bacteria on skin.
    • Recommended for repeated use.
  • Warning Section

    • For external use only
    • Flammable. Keep away from fire or flames.
  • WHEN USING

    • 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.
  • 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, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under 6, use only with adult supervision.
    • Not recommended for use on infants.
  • INACTIVE INGREDIENT

    Water, Polyaminopropyl Biguanide, Panthenol, Farnesol, PEG-12, Dimethicone, Benzethonium Chloride

  • PRINCIPAL DISPLAY PANEL

    NDC 57702-466-16

    Zylast Antiseptic S

    1000mL

    Broad Spectrum

    Antimicrobial

    1000mL

    NDC 57362-466-10

    Zylast Antiseptic S 10mL vial

    10mL

  • INGREDIENTS AND APPEARANCE
    ZYLAST ANTISEPTIC S 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57362-466
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL760 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57362-466-161000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product01/15/2019
    2NDC:57362-466-1710 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product01/15/2019
    3NDC:57362-466-4110 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product01/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/15/2019
    Labeler - Innovative BioDefense (078363903)
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