Label: PCXX ONE MINTE GEL ROOTBEER- fluoride treatment gel

  • 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 May 29, 2014

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  • PRINCIPAL DISPLAY PANEL

    PCXX ONE MINUTE RB FRONT PANEL

  • WARNINGS AND PRECAUTIONS

    PCXX ONE MINUTE RB SECONDARY PANEL

  • INGREDIENTS AND APPEARANCE
    PCXX ONE MINTE GEL ROOTBEER 
    fluoride treatment gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-028
    Route of Administrationtopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.2 mg  in 1 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorROOT BEERImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-028-161 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(62007-028)