DT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]

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DT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]
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NDC 50523-739-64
Set ID cefd65ab-dcce-4359-b33b-d3084589ecd2
Category HUMAN OTC DRUG LABEL
Packager Volume Distributors, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • Active Ingredient

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity toothpaste

  • Uses

    Aids in the prevention of cavities

  • WARNINGS

    If accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 yrs of age.

  • Directions

    Directions

    adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.

    do not swallow

    to minimize swallowing, use a pea-sized amount in children under 6 years old

    supervise children's brushing until good habits are established

    children under 2y ears: ask a dentist before use.

  • Inactive Ingredients

    Inactive ingredients-

    calcium carbonate, calcium hydrogen phosphate, sorbitol, water, hydrated alumina, sodium laryl sulfate, carboxymethylcellulose, xanthan gum, hydrated silica, glycerin, flavor, saccharin sodium, titanium dioxide, potassium sorbate FDandC blue no.1

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    DT Products
    Vernon, CA 90058

    Made in China

  • PRINCIPAL DISPLAY PANEL

    DT Fluoride Toothpaste

    Ultra Breath Freshener Stripe

    Net Wt 6.4oz (181g)

    Fresh Mint

  • PRINCIPAL DISPLAY PANEL

    Advanced Whitening Toothpaste

  • PRINCIPAL DISPLAY PANEL

    Advanced Whitening Toothpaste

  • INGREDIENTS AND APPEARANCE
    DT FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-739
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50523-739-641 in 1 BOX07/22/2011
    1181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/22/2011
    Labeler - Volume Distributors, Inc. (002029544)
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