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NDC 57511-0102-03 FluoriMax 5000 Sensitive 5; 1.1 g/100g; g/100g Details

FluoriMax 5000 Sensitive 5; 1.1 g/100g; g/100g

FluoriMax 5000 Sensitive is a TOPICAL PASTE, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Elevate Oral Care. The primary component is POTASSIUM NITRATE; SODIUM FLUORIDE.

Product Information

NDC	57511-0102
Product ID	57511-0102_ec571f65-5ee6-5de7-e053-2a95a90af041
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	FluoriMax 5000 Sensitive
Proprietary Name Suffix	n/a
Non-Proprietary Name	1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE, DENTIFRICE
Route	TOPICAL
Active Ingredient Strength	5; 1.1
Active Ingredient Units	g/100g; g/100g
Substance Name	POTASSIUM NITRATE; SODIUM FLUORIDE
Labeler Name	Elevate Oral Care
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 57511-0102-03 (57511010203)

Pricing Information	N/A
NDC Package Code	57511-0102-3
Billing NDC	57511010203
Package	96 g in 1 TUBE (57511-0102-3)
Marketing Start Date	2017-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 53bdd864-40e7-4d22-e054-00144ff88e88 Details

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

INGREDIENTS AND APPEARANCE

FLUORIMAX 5000 SENSITIVE

1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57511-0102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57511-0102-3	96 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2017	10/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/01/2017	10/31/2024

Labeler - Elevate Oral Care (002863526)

Registrant - Elevate Oral Care (002863526)

Name	Address	ID/FEI	Business Operations
Establishment
Elevate Oral Care		002863526	manufacture(57511-0102)

Revised: 10/2022

Document Id: ec571f65-5ee6-5de7-e053-2a95a90af041

Set id: 53bdd864-40e7-4d22-e054-00144ff88e88

Version: 8

Effective Time: 20221031