ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]

ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]
PDF | XML

NDC 57362-465-04
Set ID 17a70b04-3e61-27ae-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Innovative BioDefense
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Ethyl Alcohol - 76%

  • 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 or doctor.

  • DOSAGE & ADMINISTRATION

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

  • WARNINGS

    For external use only. Flammable, keep away from flame. Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water. Consult a doctor if condition persists for more than 72 hours.

  • INACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

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

  • PRINCIPAL DISPLAY PANEL

    NDC 57362-465-04

    ZylastXP Antiseptic 8oz

    Broad Spectrum

    Antimicrobial

    Non-Irritating

    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/24/2015
    Labeler - Innovative BioDefense (078363903)

Related Drugs