VORTEX (TOOTHPASTE) PASTE, DENTIFRICE [DSC LABORATORIES, DIV. OF DSC PRODUCTS INC.]

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VORTEX (TOOTHPASTE) PASTE, DENTIFRICE [DSC LABORATORIES, DIV. OF DSC PRODUCTS INC.]
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NDC 52316-028-42
Set ID 47aef72b-2f09-4d08-b2d2-01b32e9e9faf
Category HUMAN OTC DRUG LABEL
Packager DSC Laboratories, Div. of DSC Products Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • 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
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