Label: PREFENZ SILICA BASED HAND SANITIZER- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 15, 2010

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  • Active Ingredient

    Active Ingredient                                                                     Purpose

    Amosliq (Benzalkonium Chloride/Silica Complex)                     Antimicrobial

    0.12%

  • Uses

    Uses: Convenient and effective skin sanitizer and protectant.

  • Warnings

    Warning: For external use only.  Avoid contact with eyes.  In case of eye contact, flush with water.  Discontinue use if irritation or redness occurs.

  • Directions

    Directions: Apply to hands, rub together, and let dry.  Hands will be protected for up to 24 hours or up to 10 hand washings with only one application.

  • Inactive Ingredients

    Inactive Ingredients: Water, cocamidopropyl betaine, essential oil fragrance

  • Package Label

    Alcohol Free PreFenz Botanicals Silica Based Hand Sanitizer  Smooths, softens, protects  1 Application protects through 10 Hand Washings  One spray for all day Prefenz  Fresh Citrus.

    Prefenz Botanicals patented formula provides safe, all-day antibacterial protection for all strains of staph, strep, E.coli, drug resistant MRSA strains, and more.  Our Alcohol-Free formula contains moisturizing silica complex with soothing botanicals to fight drying, redness and chapping.  For everyday protection, whether at work or play, Prefenz will safeguard you and your family against today's germs.  Do Not Freeze.  US Patent #6613755.  Actual Test results indicate up to 60 hours of continuous protection.  Individual results may vary.


    8 oz label

  • INGREDIENTS AND APPEARANCE
    PREFENZ SILICA BASED HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48404-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE12 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48404-106-0144.36 mL in 1 BOTTLE
    2NDC:48404-106-02236.588 mL in 1 BOTTLE
    3NDC:48404-106-031892.7 mL in 1 BOTTLE
    4NDC:48404-106-04946.35 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2009
    Labeler - Prefense LLC (832498625)
    Registrant - Prefense LLC (832498625)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prefense LLC832498625manufacture
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