Label: FLUORIMAX 5000 SENSITIVE- 1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice
- NDC Code(s): 57511-0503-1, 57511-0503-2
- Packager: Elevate Oral Care
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 11, 2022
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Warnings
WARNINGS: Do not swallow. Keep out of reach of children under 12 yeaars of age. Read all instructions and prescribing information before using this product. Don't freeze or expose to extreme heat.
Note: 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.
- Package Label and Instructions for use
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INGREDIENTS AND APPEARANCE
FLUORIMAX 5000 SENSITIVE
1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57511-0503 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.1 g in 100 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength SACCHARIN (UNII: FST467XS7D) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score Shape ROUND Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57511-0503-2 2 in 1 BOX 06/15/2022 1 NDC:57511-0503-1 96 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 06/15/2022 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 manufacture(57511-0503)
