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
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Drug Label Information
Updated September 18, 2024
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- Active Ingredient
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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
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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.
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INGREDIENTS AND APPEARANCE
FRAICHE 5000 DENTAL MINT
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83592-814 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83592-814-04 1 in 1 CARTON 08/12/2024 1 122 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/12/2024 Labeler - True Marker Pharmaceuticals, Inc. (119046582)