Label: FRAICHE STANNOUS FLUORIDE RINSE, SPEARMINT FLAVOR- stannous fluoride liquid

  • NDC Code(s): 83592-800-04
  • Packager: True Marker Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 16, 2024

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  • Active Ingredient (s)

    Stannous fluoride, 0.63%

  • Purpose

    Anticavity/Antigingivitis

  • Uses

      Aids in the prevention of dental decay

    • helps prevent gingivitis 
    • helps interfere with harmful effects of plaque associated with gingivitis.

  • Warnings

    Keep out of reach of children under 6 years of age. If more than used
    for rinsing is swallowed, get medical help or contact a Poison Control
    Center right away. Do not swallow.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Do not use before mixing with water.
    • Adults and children 6 years of age and older:
    • Use once a day after brushing your teeth with a toothpaste.
    • Open the bottle by twisting the cap counter clockwise.
    • Pour 1/8 fl. oz. into a cup. Add water to line (1 fl. oz.) on cup.
    • Mix using bristle end of toothbrush.
    • Vigorously swish rinse between your teeth for 1 min. and then spit out.
    • Do not swallow the rinse.
    • Do not eat or drink for 30 min. after rinsing.
    • Instruct children under 12 in good rinsing habits to minimize swallowing.Supervise children as necessary until capable of using

      without supervision.

    • Children under 6: Consult a dentist or doctor.

  • Other information

    • Store at room temperature 59-86˚F (15-30˚C)
    • This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • Inactive Ingredients

    Edetic Acid, Flavor, Glycerin, Saccharin Sodium, Xylitol

  • Product label

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  • INGREDIENTS AND APPEARANCE
    FRAICHE STANNOUS FLUORIDE RINSE, SPEARMINT FLAVOR 
    stannous fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83592-800
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.63 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83592-800-041 in 1 CARTON04/04/2024
    1118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/04/2024
    Labeler - True Marker Pharmaceuticals, Inc. (119046582)