Label: VORTEX- toothpaste paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 6, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Sodium Fluoride 0.20%
  • Purpose

    Anticavity

  • Use

    Aids in prevention of dental decay.

  • 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

    • Twist off cap and remove foil seal
    • Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist.
    • Do not swallow
    • To minimize swallowing use a pea-sized amount in children under 6.
    • Supervise children's brushing until good habits are established.
    • Children under 2 yrs.: ask a dentist

  • 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

  • INGREDIENTS AND APPEARANCE
    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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!