Label: PCXX NEUTRAL GEL CREME DE MENTHE- 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 21, 2014

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    PCXX NEUTRAL MT FRONT PANEL

  • WARNINGS AND PRECAUTIONS

    PCXX NEUTRAL MT SECONDARY PANEL

  • INGREDIENTS AND APPEARANCE
    PCXX NEUTRAL GEL CREME DE MENTHE 
    fluoride treatment gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-020
    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 GREEN NO. 3 (UNII: 3P3ONR6O1S) .03 mg  in 1 mg
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorCREME DE MENTHEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-020-161 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(62007-020)