GELO-X- sodium fluoride gel, dentifrice 
Dharma Research, Inc.

----------

Storage and Handling

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

Capture

GELO-X 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-209
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION10.241 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-209-17490 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/01/2016
Labeler - Dharma Research, Inc. (078444642)
Registrant - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, Inc.078444642manufacture(53045-209)

Revised: 6/2021
Document Id: 066b3ca2-f2ce-4002-993e-a9c7efeca7f9
Set id: 8c7c6a31-a9e6-424e-abbc-053ed0284801
Version: 1
Effective Time: 20210630
 
Dharma Research, Inc.