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.
Gelato Neutral PH 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.
Storage and Handling
• 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.
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.