Label: PCXX VANILLA ORANGE NEUTRAL GL- sodium fluoride 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 February 23, 2019

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  • DOSAGE & ADMINISTRATION

    Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

    1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

    2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

    3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minute

  • PRINCIPAL DISPLAY PANEL

    principal display panel

  • INGREDIENTS AND APPEARANCE
    PCXX VANILLA ORANGE NEUTRAL GL 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-823
    Route of AdministrationDENTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 mL
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-823-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/22/2019
    Labeler - Ross Healthcare Inc. (064974821)