Label: ZYLAST ANTISEPTIC- ethyl alcohol liquid

  • 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 March 13, 2014

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  • Active Ingredients

    Ethyl alcohol 76%

  • Purpose

    Antiseptic

  • Uses

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

    • For external use only.
    • Flammable. Keep away from flame.
    • 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.

  • Directions

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

    • Store at 20-25°C (68-77°F)
  • Inactive ingredients

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

  • Active Ingredients

    Ethyl alcohol 76%

  • Purpose

    Antiseptic

  • Uses

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

    • For external use only.
    • Flammable, keepaway from flame.
    • Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.
    • Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.
    • If swallowed, immediately call Poison Control Center or doctor.
  • Directions

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

    •  Store at 20-25°C (68-77°F)
  • Inactive Ingredients

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

  • Package/Label Principal Display Panel

    NDC 57702-464-00
    Zylast
    Broad Spectrum
    Antimicrobial
    Antiseptic
    2 fl oz/ 59.1 mL

    NDC 57702-464-00 Zylast Broad Spectrum Antimicrobial Antiseptic 2 fl oz/ 59.1 mL
  • Package/Label Principal Display Panel

    NDC 57702-464-03
    Zylast
    Broad Spectrum
    Antimicrobial
    Antiseptic
    8 fl oz 236.6 mL

    Zylast Broad Spectrum Antimicrobial Antiseptic 8 fl oz 236.6 mL
  • Package/Label Principal Display Panel

    NDC 57702-464-13
    Zylast
    Broad Spectrum
    Antimicrobial
    Antiseptic
    1000mL (33.8oz)

    NDC 57702-464-13 Zylast Broad Spectrum Antimicrobial Antiseptic 1000mL (33.8oz)
  • INGREDIENTS AND APPEARANCE
    ZYLAST ANTISEPTIC 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57702-464
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.76 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FARNESOL (UNII: EB41QIU6JL)  
    WATER (UNII: 059QF0KO0R)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57702-464-0059.1 mL in 1 BOTTLE
    2NDC:57702-464-03236.6 mL in 1 BOTTLE
    3NDC:57702-464-131000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/01/2011
    Labeler - Bocchi Laboratories Inc. (078376306)
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