Label: SCOTTS SELECT APF FOAM FLUORIDE- 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 March 3, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • DESCRIPTION

    Active IngredientPurpose
    1.23% Fluoride IonFluoride Treatment Foam
  • Use

    This is a prescription fluoride treatment foam used to help prevent dental decay.

  • Warnings

    • Keep out of reach of children.
    • Do not swallow.
    • Contents under pressure.
    • Do not place in hot water or near radiators, stoves or other sources of heat.
    • Do not puncture or incinerate container. Do not spray toward open flame.
    • For professional use only.
  • Directions

    • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
    • To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
    • Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
    • Use a saliva ejector during treatment to minimize ingestion of product.
    • Remove tray(s) and have patient expectorate.
    • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.
  • Other Information

    Store at room temperature 59° –86°F (15°–30°C).

  • Inactive Ingredients

    Caster Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharine, Triethanolamine, Xylitol.

  • SPL UNCLASSIFIED SECTION

    BUBBLE GUM

    Shake well before each use

    INVERT CAN COMPLETELY AND DEPRESS NOZZLE TO DISPENSE

    Image

    Mfg for: Scott's Dental Supply
    Fife, WA 98424
    1-800-901-3368
    WWW.SCOTTSDENTAL.COM

    Rx Only
    USA
    Rev. A Date: 07/25/2016

  • PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label

    NDC 69638-067-44

    Scott's
    ✓SELECT

    APF FOAM
    With Xylitol

    Acidulated Phosphate
    Fluoride Treatment Foam

    1.23% Fluoride Ion

    1 minute or 4
    minute treatment

    4.4 fl. oz. (130mL)

    REORDER 245-2622

    GLUTEN FREE
    SCOTT'S SELECT

    SATISFACTION
    Quality
    GUARANTEED

    PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SCOTTS SELECT APF FOAM FLUORIDE 
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69638-067
    Route of AdministrationDENTAL, TOPICAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0123 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-067-44130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/22/2013
    Labeler - Scotts Dental Supply LLC (137217043)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!