Label: PRISTALL SANISHIELD ALCOHOL FREE ANTISEPTIC HAND SANITIZER- benzalkonium chloride spray

  • 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 23, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient                                                      Purpose

    Benzalkonium Chloride 0.13 percent                      Antiseptic  

  • PURPOSE

    Uses

    For hand washing to decrease bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use in eyes.

  • STOP USE

    Discontinue if irritation or redness develop. If condition persists for more than 72 hours, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS AND PRECAUTIONS

    If swallowed, get medical help or contact  a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cocoamidopropyl Betaine, Edetate Sodium USP Dihydrate, Fragrance, Hydroxypropyl Cellulose, Propylene Glycol, Water

  • DESCRIPTION

    Lot No.       Expiration Date      Made in USA   Manufactured by: Sani Home Products International, LLC 15 Frowein Road Buiding E Suite 2 Center Moriches, NY 11934

  • PRINCIPAL DISPLAY PANEL

    Pristall          SaniShield      It's not clean until it's SaniClean      Alcohol Free Antiseptic Hand Sanitizer Spray   Kills Germs Not Your Skin  8.45 fl oz (250 ml)

  • PRINCIPAL DISPLAY PANEL

    PristallSaniShieldHandSanitizerSpray250ml

  • INGREDIENTS AND APPEARANCE
    PRISTALL SANISHIELD ALCOHOL FREE ANTISEPTIC HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50757-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50757-250-08250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/23/2010
    Labeler - Sani Home Products International LLC (961615478)
    Registrant - Sani Home Products International LLC (961615478)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sani Home Products International LLC961615478manufacture
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