FDA Label for Scotts Select Apf Foam Fluoride

View Indications, Usage & Precautions

Scotts Select Apf Foam Fluoride Product Label

The following document was submitted to the FDA by the labeler of this product Scott's Dental Supply Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

STRAWBERRY

Shake well before each use

INVERT CAN COMPLETELY AND DEPRESS NOZZLE TO DISPENSE

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


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 controlled 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.


Principal Display Panel - 130 Ml Bottle Label



NDC 69638-066-44

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 245-2611

GLUTEN FREE
SCOTT'S SELECT

SATISFACTION
Quality
GUARANTEED


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