Label: GELO-X- sodium fluoride gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated June 30, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Capture

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!