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Name:Xylashield
Manufacturer:Ultradent Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Xylishield Fluoride & Xylitol Toothpaste

XYLASHIELD - sodium fluoride paste, dentifrice 
Ultradent Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Xylishield
Fluoride & Xylitol Toothpaste

Drug Facts

Active ingredient

Sodium Fluoride 0.25% w/w

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

Water (aqua), Silica, Xylitol, Glycerin, Sorbitol, Polaxamer, Sodium Lauryl Sulfate, Carbomer, Flavor (aroma), Sodium Benzoate, Sodium Hydroxide, Sodium Saccharin, Sparkle (CI 77019, CI 77891), Titanium Dioxide (CI 77891), Xanthan Gum

Questions?

800-552-5512

PRINCIPAL DISPLAY PANEL - 133 g Carton

Spearmint

Xylishield™
Fluoride & Xylitol Toothpaste

Net Wt. 4.7oz (133 g)

ULTRADENT
PRODUCTS, INC.

Principal Display Panel

XYLASHIELD 
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51206-305
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride 0.3325 g  in 133 g
Inactive Ingredients
Ingredient Name Strength
Water  
Sorbitol  
Sodium Benzoate  
Xylitol  
Silicon Dioxide  
Glycerin  
Titanium Dioxide  
Xanthan Gum  
Sodium Lauryl Sulfate  
Sodium Hydroxide  
Saccharin Sodium  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor SPEARMINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51206-305-08 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 133 g in 1 TUBE This package is contained within the BOX (51206-305-08)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 10/27/2010

Labeler - Ultradent Products, Inc. (013369916)
Establishment
Name Address ID/FEI Operations
Ultradent Products, Inc. 013369916 MANUFACTURE

Revised: 02/2011 Ultradent Products, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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