Fidelis apf aerosol, foam

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 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 for 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.

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

Ingredients and appearance - Product information

Fidelis apf aerosol, foam- Sodium fluoride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 69962-021
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 1.5375 gin 125 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Hydrofluoric acid ( UNII: RGL5YE86CZ)
Phosphoric acid ( UNII: E4GA8884NN)
Poloxamer 407 ( UNII: TUF2IVW3M2)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium laureth-3 sulfate ( UNII: BPV390UAP0)
Saccharin sodium ( UNII: SB8ZUX40TY)
Trolamine ( UNII: 9O3K93S3TK)
Xylitol ( UNII: VCQ006KQ1E)

Product Characteristics

Color white Flavor BUBBLE GUM

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 69962-021-12 125g in 1 BOTTLE, PUMP 2014/01/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA 2014/01/01

Labeler - Webco Dental & Medical Supplies, Inc.( 013554608)

Package label.principal display panel