Label: PCXX MINUTE FM LIME- sodium fluoride aerosol, foam

  • 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 3, 2015

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  • PRINCIPAL DISPLAY PANEL

    APF FM LM front panel

  • WARNINGS AND PRECAUTIONS

    APF FM LM secondary panel

  • INGREDIENTS AND APPEARANCE
    PCXX MINUTE FM LIME 
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-270
    Route of Administrationtopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.0272 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) .04 g  in 1 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1.2 mg  in 1 g
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 8.5 mg  in 1 g
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) .011 g  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE) 4.2 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLIMEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-270-07125 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/03/2015
    Labeler - Ross Healthcare Inc. (244249012)
    Registrant - Ross Healthcare Inc. (244249012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ross Healthcare Inc.244249012manufacture(62007-270)