FLUORIMAX 5000 SENSITIVE- 1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice

FluoriMax 5000 Sensitive by

Drug Labeling and Warnings

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

Drug Details [pdf]

Warnings Section

Do not swallow. Keep out of reach of children under 12 years of age. Read all the instructions and prescribing information before using this product. Do not freeze or expose to extreme heat

Package label and instructions for use

INGREDIENTS AND APPEARANCE

FLUORIMAX 5000 SENSITIVE 
1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57511-0503
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

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: 57511-0503-1	96 g in 1 TUBE; Type 0: Not a Combination Product	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/31/2020

Labeler - Elevate Oral Care (002863526)