Your browser does not support JavaScript! GELATO APF (SODIUM FLUORIDE) AEROSOL, FOAM [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]
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GELATO APF (sodium fluoride) aerosol, foam
[Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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 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 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.

Inactive Ingredients:

Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharin, Triethanolamine, Xylitol, Propellant A31.

Other Information:

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

Protect from freezing.

Shake well before each use.

Invert can completely and depress nozzle to dispense.

APFFoamCottonCandy

APFFoamBox

GELATO APF 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-134
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5375 g  in 125 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PHOSPHORIC ACID 
POLOXAMER 407 
SODIUM BENZOATE 
SODIUM LAURETH-3 SULFATE 
SACCHARIN SODIUM 
TROLAMINE 
XYLITOL 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-134-12125 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/27/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194)
Establishment
NameAddressID/FEIBusiness Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.078654194manufacture(68400-134), label(68400-134)

Revised: 11/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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