Scotts select apf gel

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 86F (15-30C). Protect from freezing.

Ingredients and appearance - Product information

Scotts select apf gel- Sodium fluoride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 69638-052
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 5.6 gin 454 g

Inactive Ingredients

Ingredient Name Code
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

Flavor MARSHMALLOW Color pink

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Scott's Dental Supply, LLC( 137217043)

Package label.principal display panel