Label: DT FLUORIDE- sodium monofluorophosphate 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 February 16, 2018

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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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