Just Right 5000

JUST RIGHT 5000- sodium fluoride gel, 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.

Warning

Do not swallow. Keep out of reach of children under 6 years of age. Read all instructions and prescribing information before using this product. Do not freeze or expose to extreme heat.

Package label and instruction for use

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

JUST RIGHT 5000
1.1% sodium fluoride toothpaste gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57511-0002
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 red Score
Shape ROUND Size
Flavor APPLE (Candy Apple) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57511-0002-1 97 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/28/2020
Labeler — Elevate Oral Care (002863526)
Registrant — Elevate Oral Care (002863526)
Establishment
Name Address ID/FEI Operations
Elevate Oral Care 002863526 manufacture (57511-0002)

Revised: 02/2021 Elevate Oral Care

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