XYLISHIELD- 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.

----------

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
XYLISHIELD 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-305
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Xylitol (UNII: VCQ006KQ1E)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Glycerin (UNII: PDC6A3C0OX)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51206-305-081 in 1 BOX10/27/201001/09/2015
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/27/201001/09/2015
Labeler - Ultradent Products, Inc. (013369916)
Establishment
NameAddressID/FEIBusiness Operations
Ultradent Products, Inc.013369916MANUFACTURE(51206-305)

Revised: 5/2016
Document Id: c4e789b5-5aac-4e72-95f5-fe5af665e0b6
Set id: 5adfde64-2e67-4b5a-982b-ac03c78d2a32
Version: 4
Effective Time: 20160524
 
Ultradent Products, Inc.