Label: GELATO APF- sodium fluoride aerosol, foam
- NDC Code(s): 68400-116-12
- Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated November 19, 2013
If you are a consumer or patient please visit this version.
- Active Ingredient:
1.23% Fluoride Ion. Available from 1.81% Sodium Fluoride and Hydrofluoric Acid.Close
Fluoride Preventative Treatment Foam.Close
- Indications and Usage:
This is a prescription fluoride treatment foam used to help prevent dental decay.Close
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.Close
- 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 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.
- Inactive Ingredients:
Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharin, Triethanolamine, Xylitol, Propellant A31.Close
- 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.Close
- INGREDIENTS AND APPEARANCE
sodium fluoride aerosol, foam
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-116 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5375 g in 125 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 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 Score Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68400-116-12 125 g in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/27/2013 Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (078654194) Establishment Name Address ID/FEI Business Operations Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 078654194 manufacture(68400-116) , label(68400-116)