Xylishield

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 0.3325g in 133g
Labeler: Ultradent Products, Inc.
NDC Code: 51206-305

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.

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.

XYLISHIELD 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-305
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.3325 g  in 133 g
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Sodium Benzoate 
Xylitol 
Silicon Dioxide 
Glycerin 
Titanium Dioxide 
Xanthan Gum 
Sodium Lauryl Sulfate 
Sodium Hydroxide 
Saccharin Sodium Dihydrate 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51206-305-081 TUBE in 1 BOX
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/27/2010
Labeler - Ultradent Products, Inc. (013369916)
Establishment
NameAddressID/FEIOperations
Ultradent Products, Inc.013369916MANUFACTURE(51206-305)

Revised: 06/2012
 
Ultradent Products, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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