Label: MYNTSMILE DIAMYNT- 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 March 10, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Sodium Monofluorophosphate 0.83% w/w

  • PURPOSE

    Purpose:

    Anti cavity toothpaste.

  • INDICATIONS & USAGE

    Uses:

    Aids in the prevention of dental cavities.

  • WARNINGS

    Warnings:

    As with all fluoride toothpastes, Keep out of reach of children under 6 yrs of age.

    If you accidentally swallow more than used for brushing, get medical help or contact a poison control center right away.

  • KEEP OUT OF REACH OF CHILDREN


  • DOSAGE & ADMINISTRATION

    Directions

    For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing.

    Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Glycerin, Hydrated Silica, Sorbitol, Xanthan Gum, Titanium Dioxide, Flavor, Cocamidopropyl Betaine, Xylitol, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extarct, Diamond Powder

  • SPL UNCLASSIFIED SECTION

    Questions: 1-855-MYNT-SMILE

    www.myntsmile.com

    PATENT PENDING FORMULA

    Distributed by:

    LMKAO LLC, New York, NY

    10006 Made in USA

  • PRINCIPAL DISPLAY PANEL






    DIAMYNT TUBE LABEL

    DIAMYNT TUBE LABEL

  • PRINCIPAL DISPLAY PANEL






    DIAMYNT BOX LABEL

    DIAMYNT BOX LABEL

  • INGREDIENTS AND APPEARANCE
    MYNTSMILE  DIAMYNT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42357-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.83 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    SAGE (UNII: 065C5D077J)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    DIAMOND (UNII: 6GRV67N0U2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42357-001-011 in 1 BOX
    1112 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/10/2012
    Labeler - LMKAO LLC (078346159)
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