FluoriMax 5000

FLUORIMAX 5000- sodium fluoride 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.

Warnings

Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product.

Label and instruction for use

Primary package label
(click image for full-size original)

FLUORIMAX 5000
1.1% sodium fluoride toothpaste paste, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57511-0504
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) 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 Multilevel Packaging
1 NDC:57511-0504-1 96 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2020
Labeler — Elevate Oral Care (002863526)
Registrant — Elevate Oral Care (002863526)
Establishment
Name Address ID/FEI Operations
Elevate Oral Care 002863526 manufacture (57511-0504)

Revised: 09/2020 Elevate Oral Care

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