FLUORIDEX DAILY DEFENSE ENHANCED WHITENING- sodium fluoride 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.

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Fluoridex Daily Defense Enhanced Whitening Clean Mint

WARNINGS AND PRECAUTIONS

DO NOT SWALLOW. Keept out of reach of children under 6 years of age. Read all instructions and prescribing information before using this product.

DIRECTIONS FOR USE: This prescription toothpaste is recommended for adults and children 6 years of age and older. Use twice daily as your normal dentifrice or as directed by your dental professional.

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.
After use, adults expectorate. For best results do not eat, drink, or rinse for 30 minutes. Pediatric patients age 6-16, expectorate after use and rinse mouth thoroughly.

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

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

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

Outer Carton

Tube Label

FLUORIDEX DAILY DEFENSE ENHANCED WHITENING
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64854-020
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.011 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MINT (UNII: FV98Z8GITP)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLOXAMER 234 (UNII: 66EV99AS9E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	green (with sparkles)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64854-020-01	1 in 1 PACKAGE	02/27/2015	12/31/2016
1		112 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/27/2013	12/31/2016

Labeler - Discus Dental, LLC (831726109)

Name	Address	ID/FEI	Business Operations
Establishment
Discus Dental, LLC		831726109	manufacture(64854-020)

Revised: 10/2015

Document Id: ad6f597c-a7c8-4ed0-80cc-952e849db174

Set id: d05f94c8-3020-4f7c-877a-d64d6841a122

Version: 4

Effective Time: 20151021

Discus Dental, LLC