Label: FLUORIMAX 5000 SENSITIVE- 1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice
- NDC Code(s): 57511-0102-3
- Packager: Elevate Oral Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 31, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride 1.1% Anticavity
Potassium Nitrate 5% Antisensitivity
INDICATIONS & USAGE SECTION
A dental caries preventive and sensitive teeth toothpaste for once daily self appied topical use. It is well established that 1.1% sodium fluoride is safe and effective as a caries preventive when applied frequently with mouthpiece applicators. Use once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.
WARNINGS SECTION
Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if water fluoridation exceeds 0.7 ppm, since younger patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 requires special supervision to preven repeated swallowing of dental cream which could cause dental fluorosis. Read instructions carefully before using. Keep out of reach of infants and children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of infants and children.
INSTRUCTIONS FOR USE SECTION
Directions: *adults and children 2 years and older: wet a toothbrush and apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.
INACTIVE INGREDIENT SECTION
Inactive ingredients; sorbitol, deionized water, hydrated silica, xylitol, glycerin, PEG 400, sodium lauryl sulfate, potassium phosphate monobasic, titanium dioxide, vanilla mint flavor, sodium saccharin
OTC - QUESTIONS SECTION Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
OTC - PURPOSE SECTION Helps protect against Cavities and relieve dentinal hypersensitivity
DOSAGE & ADMINISTRATION SECTION Directions: adults and pediatric patients 6 and older, apply a thin ribbon of FluoriMax toothpaste to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bed time. After use, adults spit, do not eat, drink or rinse for 30 minutes. Pediatric patients 6-16 spit after use and rinse mouth thoroughly.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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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 OTC DRUG Item Code (Source) NDC:57511-0102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN (UNII: FST467XS7D) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) XYLITOL (UNII: VCQ006KQ1E) 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:57511-0102-3 96 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2017 10/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2017 10/31/2024 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 manufacture(57511-0102)
