Fluoridex Daily Defense Sensitivity Relief SLS Free

FLUORIDEX DAILY DEFENSE SENSITIVITY RELIEF SLS FREE- sodium fluoride and potassium nitrate paste, dentifrice
Discus Dental, LLC

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 AND PRECAUTIONS

DO NOT SWALLOW. Keept out of reach of children under 12 years of age. Read all instructions and prescribing information before using this product. 

Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Outer Carton

Outer Carton
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Tube Label

Tube Label
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DIRECTIONS FOR USE: This prescription toothpaste is recommended for adults and children 12 years of age and older. Use twice daily as your normal dentifrice or as directed by your dental professional.

  1. Apply a thin ribbon or pea-sized amount of Fluoridex Daily Defense® Sensitivity Relief Toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute.
  2. After use, adults expectorate. For best results do not eat, drink, or rinse for 30 minutes. Pediatric patients age 12-16, expectorate after use and rinse mouth thoroughly.

INDICATIONS AND USAGE: Prescription fluoride toothpaste for use as part of a professional program for the prevention and control of dental caries

STORAGE AND HANDLING SECTION: Store at controlled room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENTS: Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol

FLUORIDEX DAILY DEFENSE SENSITIVITY RELIEF SLS FREE
1.1% sodium fluoride, 5% potassium nitrate paste, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64854-030
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION .011 in 1 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE .05 in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE
COCAMIDOPROPYL BETAINE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MINT
GLYCERIN
MICA
TITANIUM DIOXIDE
POLOXAMER 234
SILICON DIOXIDE
SACCHARIN SODIUM
SORBITOL
WATER
XYLITOL
Product Characteristics
Color green (with sparkles) Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 0-7502004873-8 1 TUBE in 1 PACKAGE contains a TUBE (64854-030-01)
1 NDC:64854-030-01 112 g in 1 TUBE This package is contained within the PACKAGE (0-7502004873-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/27/2013
Labeler — Discus Dental, LLC (831726109)
Registrant — Discus Dental, LLC (831726109)
Establishment
Name Address ID/FEI Operations
Discus Dental, LLC 831726109 manufacture (64854-030)

Revised: 04/2015 Discus Dental, LLC

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