Label: FRESHMINT PREMIUM ANTICAVITY GEL- sodium fluoride paste, dentifrice

  • NDC Code(s): 51824-046-01, 51824-046-02, 51824-046-03, 51824-046-04
  • 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, Polyethylene Glycol 1500, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, Methylparaben, Tetrasodium Pyrophosphate, Propylparaben, FD&C Blue # 1

  • PRINCIPAL DISPLAY PANEL

    ADA Tube
  • INGREDIENTS AND APPEARANCE
    FRESHMINT PREMIUM ANTICAVITY GEL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-046
    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)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorblue (Aqua Blue) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-046-02144 in 1 CARTON01/01/2015
    1NDC:51824-046-0128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51824-046-0472 in 1 CARTON01/01/2015
    2NDC:51824-046-0385 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2015
    Labeler - New World Imports, Inc (075372276)
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