Label: FLUORIMAX 5000- 1.1% sodium fluoride toothpaste paste, dentifrice
- NDC Code(s): 57511-0101-3
- Packager: Elevate Oral Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 13, 2021
If you are a consumer or patient please visit this version.
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OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride 1.1% Anticavity
INDICATIONS & USAGE SECTION
A dental caries preventive 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 pump once to apply a pea-sized (~0.35 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 pump once to 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
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
1.1% sodium fluoride toothpaste paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57511-0101 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 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:57511-0101-3 96 g in 1 TUBE; Type 0: Not a Combination Product 02/02/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/01/2015 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 manufacture(57511-0101)
