FRESHMINT ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]

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FRESHMINT ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]
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NDC 51824-067-01, 51824-067-02, 51824-067-03, 51824-067-04, 51824-067-05, 51824-067-06, 51824-067-07, 51824-067-08, 51824-067-09
Set ID 77e51d6f-c1a2-4650-b3dd-5e4552379e77
Category HUMAN OTC DRUG LABEL
Packager New World Imports, Inc
Generic Name
Product Class
Product Number
Application Number PART355
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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate - .76%

    (Total Fluoride Content - 1000 ppm Approx.)

  • PURPOSE

    Anticavity

  • KEEP OUT OF REACH OF CHILDREN

    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 immediately.

  • INDICATIONS & USAGE

    Helps protect against cavities

  • WARNINGS

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

  • DOSAGE & ADMINISTRATION

    Adults and Children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

    Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

    Children under 2 years: Ask a dentist of physician.

  • INACTIVE INGREDIENT

    Calcium Carbonate, Treated Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Flavor, Sodium Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methylparaben, Titanium Dioxide, Polyethylene Glycol 400, Propylparaben

  • PRINCIPAL DISPLAY PANEL

    White Paste Tube

  • INGREDIENTS AND APPEARANCE
    FRESHMINT ANTICAVITY FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-067
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Carbonate (UNII: H0G9379FGK)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Sodium Silicate (UNII: IJF18F77L3)  
    Sodium phosphate, tribasic, dodecahydrate (UNII: B70850QPHR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (White) Score    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-067-0117 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    2NDC:51824-067-0217 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    3NDC:51824-067-0324 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    4NDC:51824-067-0443 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    5NDC:51824-067-0543 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    6NDC:51824-067-0678 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    7NDC:51824-067-0778 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    8NDC:51824-067-08130 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    9NDC:51824-067-09181 g in 1 TUBE; Type 0: Not a Combination Product09/16/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/16/2010
    Labeler - New World Imports, Inc (075372276)
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