PureLife APF description, usages, side effects, indications, overdosage, supplying and lots more!

PureLife APF

PureLife Dental

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient:

1.23% Fluoride Ion.

Available from 1.81% Sodium Fluoride and Hydrofluoric Acid.

Purpose:

Fluoride Preventative Treatment Foam.

Indications and Usage:

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

Warnings:

Do not swallow. Keep out of reach of children. 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.

Instructions for Use

  • 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 fluoride tray (foam will expand slightly higher than the 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 for 1-4 minutes.
  • Use a saliva ejector during treatment to minimize ingestion of the product.
  • Remove tray(s) and have patient expectorate.
  • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Inactive Ingredients

Distilled Water, Flavor, Hydrofluoric Acid, Isobutane Propane Propellant, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharin, Triethanolamine, Xylitol.

Other Information:

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

Protect from freezing.

PureLife APF

Sodium Fluoride AEROSOL, FOAM

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68987-022
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 1.5375 g

Inactive Ingredients

Ingredient Name Strength
water
Hydrofluoric Acid
phosphoric acid
POLOXAMER 407
SODIUM BENZOATE
SODIUM LAURETH-3 SULFATE
saccharin sodium
TROLAMINE
Xylitol

Product Characteristics

Color
white

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68987-022-12 125 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-03-27


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