Scotts Select APF

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.

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, FD&C Yellow #5 (tartrazine) as a color additive, 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.

SCOTTSAPFVANILLAORANGE
(click image for full-size original)

SCOTTS SELECT APF
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69638-055
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5.6 g in 454 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
WATER
XANTHAN GUM
XYLITOL
FD&C RED NO. 40
FD&C YELLOW NO. 5
Product Characteristics
Color orange Score
Shape Size
Flavor VANILLA, ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69638-055-15 454 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2013
Labeler — Scott’s Dental Supply, LLC (137217043)

Revised: 02/2015 Scott’s Dental Supply, LLC

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