Label: FRAICHE 5000 SENSITIVE- sodium fluoride,potassium nitrite gel
- NDC Code(s): 83592-816-04
- 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 March 14, 2024
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- Active Ingredient (s)
- PURPOSE
- Uses
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Warnings
Do no 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. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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.
- Adverse reactions
- Children under 6 years of age
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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. Make sure to brush all sensitive areas of the teeth.
Children under 6 years of age: Consult a dentist or physician. - Dosage form and Strengths
- Contraindications
- Description
- Inactive Ingredients
- How supplied/storage
- Product label
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INGREDIENTS AND APPEARANCE
FRAICHE 5000 SENSITIVE
sodium fluoride,potassium nitrite gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83592-816 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 POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608) POTASSIUM NITRITE 4.5 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:83592-816-04 1 in 1 CARTON 03/12/2024 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 03/12/2024 Labeler - True Marker Pharmaceuticals, Inc. (119046582)