SCOTTS SELECT APF- sodium fluoride gel 
Scott's Dental Supply, LLC

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.

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Active Ingredient:                                            Purpose:

Flouride Ion 1.23% .................... Flouride Treatment Gel

Available from 2.09% Sodium Flouride and Hydroflouric Acid.

Indications and Usage:

A stable thixotropic gel used to help prevent dental decay. For professional use only. This product is not intended for home or unsupervised consumer use.

Warning:

  • Keep out of reach of children.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
  • Read directions carefully before using.

Dosage and Administration:

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

  1. After thorough prophylaxis, 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 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 minutes.

Inactive Ingredients:

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

Other Information:

  • Store at controlled room temperature 59° to 86°F (15°-30°C). Protect from freezing.

SCOTTSAPFSTRBRY

SCOTTS SELECT APF 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69638-054
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5.6 g  in 454 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69638-054-15454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/201301/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/201301/20/2019
Labeler - Scott's Dental Supply, LLC (137217043)

Revised: 2/2019
 
Scott's Dental Supply, LLC