Label: FRAICHE 5000 DENTAL MINT- sodium fluoride gel

  • NDC Code(s): 83592-814-04
  • Packager: True Marker Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 18, 2024

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  • Active Ingredient 

    1.1% neutral sodium fluoride

  • Purpose

    Dental gel

  • Uses

    This is a fluoride dental gel intended for use as dental caries preventive in adults and pediatric patients.

  • Warnings

    Do not swallow. Keep out of reach of children. Read the prescribing information fully before using this product. If the product is accidentally swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

    Contraindications: Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 6 unless directed by a dentist or physician.

  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 Years of Age: Consult a dentist or physician.

  • Directions

    Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician. Adults and children 6 years of age and older. Twist off cap and remove foil seal. Apply at least a 1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly.

  • Other information

    To report suspected adverse reactions, contact True Marker Pharmaceuticals at (877) 887-9879 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

  • Inactive Ingredients

    Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Sorbitol, Xanthan Gum, Flavor, Yucca Shidigera Root Extract, Quillaja Saponaria Bark Extract, Smilax Aristolochiaefolia Root Extract, Dioscorea Villosa Root Extract, Tocopheryl Acetate,Cocamidopropyl Betaine, Benzyl Alcohol.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    FRAICHE 5000 DENTAL MINT 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:83592-814
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83592-814-041 in 1 CARTON08/12/2024
    1122 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/12/2024
    Labeler - True Marker Pharmaceuticals, Inc. (119046582)