Label: ZYLAST ANTISEPTIC SURGICAL SCRUB- 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 February 24, 2014

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  • Active Ingredients

    Ethyl alcohol 76%

  • Purpose

    Antiseptic

  • Uses

    • Scrub significantly reduces the number of micro-organisms on the hands and forearms prior to surgery.
  • Warnings

    • For external use only.
    • Flammable. Keep away from flame.
    • Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.
    • Discontinue use if irritation and redness develops.
  • Directions

    • Clean under nails that have a free edge of 1 mm with a nail pick. Place enough product on hands to completely spread over both hands and wrists, paying attention to nails, cuticles and interdigital spaces. Rub into skin until dry.

  • 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 57702-466-16
    Zylast
    Antiseptic
    Surgical Scrub
    1000mL (33.8oz)NDC 57702-466-16 Zylast Antiseptic Surgical Scrub 1000mL (33.8oz)

  • INGREDIENTS AND APPEARANCE
    ZYLAST ANTISEPTIC SURGICAL SCRUB 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57702-466
    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:57702-466-161000 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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