Label: PCXX NEUTRAL FOAM BAZOOKA BUBBLEGUM- fluoride treatment aerosol, foam

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 5, 2014

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  • PRINCIPAL DISPLAY PANEL

    PCXX NEUTRAL FOAM BAZOOKA BUBBLEGUM FRONT PANEL

  • WARNINGS AND PRECAUTIONS

    PCXX NEUTRAL FOAM BAZOOKA BUBBLEGUM SECONDARY PANEL

  • INGREDIENTS AND APPEARANCE
    PCXX NEUTRAL FOAM BAZOOKA BUBBLEGUM 
    fluoride treatment aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-104
    Route of Administrationtopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20.0 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 35 mg  in 1 mg
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-104-071 mg in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/21/2014
    Labeler - Ross Healthcare Inc. (244249012)
    Registrant - Ross Healthcare Inc. (244249012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ross Healthcare Inc.244249012manufacture(62007-104)