SPRY XYLITOL CINNAMON - sodium fluoride paste, dentifrice 
Xlear 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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Spry Xylitol Cinnamon Toothpaste

Drug Facts

Active ingredient

Sodium Fluoride 0.25% (w/w)

Purpose

Anticavity toothpaste

Indication

Aids in the prevention of dental cavities.

Warning

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 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).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor

Inactive ingredients

Aqua (Purified Water), Xylitol, Silica, Vegetable Glycerin, Sorbitol, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Aloe Vera, Calcium Glycerophosphate, Natural Cinnamon Flavor, Sodium Benzoate, Stevia Rebaudiana Leaf/Stem Extract, Titanium Dioxide, Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 113 G Tube Box

NDC-27017-054-01

XYLITOL
CINNAMON

Spry
TOOTHPASTE
DENTAL DEFENSE SYSTEM®

WITH
Fluoride

Fights
Cavities

4 OZ / 113 G

Principal Display Panel - 113 G Tube Box
SPRY XYLITOL CINNAMON  
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27017-054
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.28 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Xylitol (UNII: VCQ006KQ1E)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
Xanthan Gum (UNII: TTV12P4NEE)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Calcium Glycerophosphate (UNII: XWV9Z12C1C)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27017-054-011 in 1 BOX02/01/201212/31/2018
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/201212/31/2018
Labeler - Xlear Inc. (839884058)

Revised: 9/2018
Document Id: 6e8c2b55-fbdc-47a6-9153-509ea0d9c37e
Set id: cc437dcd-1335-4782-9dc6-afeba6b65317
Version: 2
Effective Time: 20180905
 
Xlear Inc.