Label: PCXX- sodium fluoride aerosol, foam

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 17, 2012

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  • Active Ingredient

    ACTIVE INGREDIENT: 2.0% Sodium Fluoride

  • Use

    Use: Professional Use Anticavity Treatment

  • Keep Out Of Reach Of Children

    Keep out of reach of children.

  • Use

    Use: Professional Use Anticavity Treatment

  • Cautions and Warnings

    Cautions and Warnings:

    Keep out of reach of children. Rx only. Do not puncture or incinerate. Do not store above 50 degrees C. Do not use in the presence of open flame. Contents under pressure. Do not place near any heat source.

  • Directions For Use

    DIRECTIONS FOR USE:

    1. Use after prophylaxis.

    2. Shake bottle vigorously for 3-4 seconds.

    3. For adults and children age 6 and older.

    4. Invert applicator.

    5. Place nozzle to applicator tray and dispense.

    6. Allow foam to expand in tray.

    7. Have patient bite down for up to 4 minutes.

    8. Remove trays and have patient expectorate excess.

    9. Do not eat or drink for 30 minutes after use.

  • Inactive Ingredients

    INACTIVE INGREDIENTS: Glycerin, Xylitol, Sucralose, Poloxamer, Sodium Lauryl Sulphate, Xantham Gum, Flavour, Potassium Sorbate.

  • Product Label

    PCxx

    Professional Care Products

    NEUTRAL FOAM

    TOPICAL FLUORIDE FOAM

    2.0% Sodium Fluoride

    NO FLAVOR

    Net Contents: 125 g

    NPN# 800004635

    NDC# 062007-105-07

    Ross Healthcare Inc.  1-800-663-8303 / www.rosshealthcare.org

    Made in Canada

    LOT 27121A6

    EXPIRY 12-2014

    Ross Healthcare PCxx Label

  • INGREDIENTS AND APPEARANCE
    PCXX 
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-105
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.5 g  in 125 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62007-105-07125 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/12/2012
    Labeler - Ross Healthcare Inc. (244249012)
    Registrant - Ross Healthcare Inc. (244249012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ross Healthcare Inc.244249012manufacture(62007-105)
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