Gelato APF

GELATO APF- sodium fluoride gel
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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.

Fluoride Ion 1.23% ………………………. Fluoride Treatment Gel
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Indications and usage:

• A stable thixotropic fluoride treatment gel used to help prevent dental decay.
• For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

Warnings:

• Keep out of reach of children.
• Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
• Read directions carefully before using.

Dosage and administration:

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.

1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Inactive ingredients:

Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xantham Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.

Other information:

• Do not store above 25°C/77°F. Do not freeze.

GELATO APF sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-313 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5.6 g in 454 g

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 SODIUM BENZOATE SACCHARIN SODIUM TITANIUM DIOXIDE WATER XANTHAN GUM XYLITOL FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6

Product Characteristics Color white (Dye Free) Score Shape Size Flavor VANILLA Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68400-313-15 454 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2014

Labeler — Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)

Establishment
Name	Address	ID/FEI	Operations
Keystone Industries		014769301	manufacture (68400-313), label (68400-313)

Revised: 01/2022 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.