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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FluoriMax 5000 1.1% Sodium Fluoride & 5% Potassium Nitrate Toothpaste

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

Primary package label

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

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

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

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

Labeler - Elevate Oral Care (002863526)