Label: PCXX NEUTRAL RMS BUBBLEGUM- fluoride treatment rinse

  • 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 March 20, 2024

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  • WARNINGS AND PRECAUTIONS

    NEUTRAL RINSE BG BACK PANEL

  • PRINCIPAL DISPLAY PANEL

    NEUTRAL RINSE BG FRONT PANEL

  • INGREDIENTS AND APPEARANCE
    PCXX NEUTRAL RMS BUBBLEGUM 
    fluoride treatment rinse
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-213
    Route of AdministrationTOPICAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.04 mg  in 1 mL
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-213-641900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/20/2015
    Labeler - Ross Healthcare Inc. (064974821)
    Registrant - Ross Healthcare Inc. (064974821)