VORTEX - toothpaste paste, dentifrice 
DSC Laboratories, Div. of DSC 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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Drug Facts

Active Ingredients

Sodium Fluoride 0.20%

Purpose

Anticavity

Use

Aids in prevention of dental decay.


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


Inactive Ingredients

Purified water, Glycerin, Xylitol, Hydrated Silica, Carbomer Homopolymer Type C, Natural Grape Flavor, Xanthan Gum, D and C Red #28, FD and C Blue #1, D and C Red #33.

Questions?

Call 1-314-436-3332

VORTEX TOOTHPASTE 120G TUBE

Vortex Anti-Cavity Fluoride  Toothpaste

Net Wt. 4.2 oz (120g)

Distributed by: Wright Toothpaste Inc.

St. Louis, MO 63127

VORTEX TOOTHPASTE 120G TUBE

VORTEX 
toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52316-028
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52316-028-42120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/30/2011
Labeler - DSC Laboratories, Div. of DSC Products Inc. (097807374)
Establishment
NameAddressID/FEIBusiness Operations
DSC Laboratories, Div. of DSC Products Inc.097807374manufacture

Revised: 12/2011
Document Id: 8ecf77c1-f102-4992-a08e-6f3d42a6036b
Set id: 47aef72b-2f09-4d08-b2d2-01b32e9e9faf
Version: 1
Effective Time: 20111206
 
DSC Laboratories, Div. of DSC Products Inc.