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FluoriMax 5000

Medically reviewed on Jan 31, 2018

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1mg
Labeler: Elevate Oral Care
NDC Code: 57511-0101

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.

FluoriMax 5000 1.1% Sodium Fluoride Toothapste

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)

FLUORIMAX 5000 
1.1% sodium fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
SACCHARIN 
POTASSIUM PHOSPHATE, MONOBASIC 
XYLITOL 
Product Characteristics
ColorwhiteScore    
ShapeROUNDSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57511-0101-396000 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2015
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIOperations
Elevate Oral Care002863526manufacture(57511-0101)

 
Elevate Oral Care

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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