FLUORIMAX 5000- 1.1% sodium fluoride toothpaste paste, dentifrice

FluoriMax 5000 by

Drug Labeling and Warnings

FluoriMax 5000 by is a Otc medication manufactured, distributed, or labeled by Elevate Oral Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

FluoriMax 5000 Fluoride Toothapste Cavity Protection.  Net Wt 3.4oz (96g)

INGREDIENTS AND APPEARANCE

FLUORIMAX 5000 
1.1% sodium fluoride toothpaste paste, dentifrice

Product 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)