Label: PCXX REMIN 0.4- 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 March 11, 2019

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  • WARNINGS AND PRECAUTIONS

    SECONDARY PANEL RMN

  • PRINCIPAL DISPLAY PANEL

    Front Panel RMG

  • INGREDIENTS AND APPEARANCE
    PCXX REMIN 0.4 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.02 mg  in 1 mg
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-041-021 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/16/2015
    Labeler - Ross Healthcare Inc. (064974821)