GELO-X- sodium fluoride gel, dentifrice

gelo-X by

Drug Labeling and Warnings

gelo-X by is a Prescription medication manufactured, distributed, or labeled by Dharma Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Storage and Handling

• Store at 59° – 86° F (15° – 30° C)
• Protect from freezing
• Product is free of gluten, soy milk, egg, peanut, and tree nut products

Inactive Ingredients

Citric acid, FD&C Red No. 40 (C.I. 16035), Flavor, Hydrofluoric Acid, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharine, Sweetness enhancer, Titanium dioxide, Tocopherol acetate, Xanthan gum, Xylitol

Warnings and Precautions

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

Do not use on patients with an allergy to fluoride

Product contains artificial color; confirm that no known patient allergies exist

For professional use only

Instructions for Use

Shake well before use
This is a four minute or one minute fluoride gel for in-office patient use.
For best results, use at least twice per year
After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into mouth.
Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness)
Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELO-X 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53045-209
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.241 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ISOPROPYL ETHER (UNII: 19776V0481)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53045-209-17	490 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		01/01/2016

Labeler - Dharma Research, Inc. (078444642)

Registrant - Dharma Research, Inc. (078444642)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, Inc.		078444642	manufacture(53045-209)