Primo APF

PRIMO APF- sodium fluoride aerosol, foam
Tri State Dental Supply

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:

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.

PRIMOFOAMCC
(click image for full-size original)

PRIMO APF
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69509-080
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5375 g in 125 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 Score
Shape Size
Flavor COTTON CANDY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69509-080-12 125 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2013
Labeler — Tri State Dental Supply (176048478)

Revised: 02/2015 Tri State Dental Supply

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