Label: FRESHMINT PREMIUM ANTICAVITY- sodium fluoride paste, dentifrice

  • NDC Code(s): 51824-034-01, 51824-034-09
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • OTC Active Ingredient

    Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)

  • OTC Purpose

    Anticavity

  • Keep out of reach of Children under 6 years of age

    If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

  • Uses

    Helps protect teeth and roots against cavities.

  • Warnings

    Keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 years & older:

    • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
    • Do not swallow.
    • To minimize swallowing use a pea-sized amount in children under 6 years of age.
    • Supervise children's brushing until good habits are established.

    Children under 2 years:

    • Ask a dentist
  • Inactive Ingredients

    Sorbitol, Silica, Treated Water (aqua), Glycerin, Polyethulene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD&C Blue #1

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FRESHMINT PREMIUM ANTICAVITY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-034
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    POTASSIUM SODIUM SACCHARATE DIHYDATE (UNII: 6SI0K9D9KF)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (sky blue) Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-034-01130 g in 1 TUBE; Type 0: Not a Combination Product04/04/2013
    2NDC:51824-034-098 g in 1 PACKET; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/04/2013
    Labeler - New World Imports, Inc (075372276)
    Registrant - New World Imports, Inc (075372276)
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