Label: PCXX NEUTRAL GEL RASPBERRY BLAST- fluoride treatment gel

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

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Drug Label Information

Updated May 21, 2014

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  • PRINCIPAL DISPLAY PANEL

    PCXX NEUTRAL BG FRONT PANEL

  • WARNINGS AND PRECAUTIONS

    PCXX NEUTRAL RS SECONDARY PANEL

  • INGREDIENTS AND APPEARANCE
    PCXX NEUTRAL GEL RASPBERRY BLAST 
    fluoride treatment gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-026
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA) .01 mg  in 1 mg
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-026-161 mg in 1 BOTTLE, PLASTIC
    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(62007-026)