GELATO NEUTRAL PH- sodium fluoride gel

Gelato Neutral pH by

Drug Labeling and Warnings

Gelato Neutral pH by is a Prescription medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Sodium Fluoride 2%

Purpose:

Fluoride Treatment Gel

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 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 four minutes.

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

Other Information:

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

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELATO NEUTRAL PH 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68400-115
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	4.086 g  in 454 g

Inactive Ingredients
Ingredient Name	Strength
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Phosphoric Acid (UNII: E4GA8884NN)
Polysorbate 20 (UNII: 7T1F30V5YH)
Potassium Hydroxide (UNII: WZH3C48M4T)
Sodium Benzoate (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)
Xylitol (UNII: VCQ006KQ1E)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-115-15	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2013

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.		014769301	manufacture(68400-115) , label(68400-115)