Label: ZYLAST ANTISEPTIC- ethyl alcohol gel

  • 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, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol - 76%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    • To decrease bacteria on skin.
    • Recommened for repeated use.
  • ASK DOCTOR

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

  • WARNINGS

    • 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.
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact Poison Control center right away.

  • DOSAGE & ADMINISTRATION

    • 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.
  • STORAGE AND HANDLING

    • Store at 20-25 degrees Celsius (68-77 degrees Farenheit)
  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    NDC 57362-465-04

    Zylast Antiseptic 8oz

    Broad Spectrum

    Antimicrobial

    Non-Irritating

    Zylast 8 oz

    NDC: 57362-465-48

    CB Antiseptic label

  • INGREDIENTS AND APPEARANCE
    ZYLAST ANTISEPTIC 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57362-465
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL44.9 mL  in 59.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57362-465-04236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2019
    2NDC:57362-465-48250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/24/2015
    Labeler - Innovative BioDefense (078363903)