Label: FLUORIMAX 5000- 1.1% sodium fluoride toothpaste paste, dentifrice
- NDC Code(s): 57511-0504-1, 57511-0504-2
- 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 September 19, 2025
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INGREDIENTS AND APPEARANCE
FLUORIMAX 5000
1.1% sodium fluoride toothpaste paste, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57511-0504 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 Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) SACCHARIN (UNII: FST467XS7D) 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:57511-0504-2 2 in 1 BOX 06/15/2022 1 NDC:57511-0504-1 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(57511-0504)
