Label: FRESHMINT PREMIUM ANTICAVITY- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC Monograph Drug Product Manufactured Exclusively for Private Label Distributor

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/08

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT:

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

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  • PURPOSE:

    Anticavity

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  • USES:

    Helps protect teeth and roots against cavities.

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  • 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.

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  • 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.
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  • INACTIVE INGREDIENTS:

    Sorbitol, Silica, Treated Water (Aqua), Glycerin, Polyethylene 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.

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    ADA
    Accepted
    American
    Dental
    Association®

    freshmint®

    Premium Anticavity Toothpaste

    NET WT. 0.85 oz

    Principal Display Panel – Tube Label
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  • INGREDIENTS AND APPEARANCE
    FRESHMINT PREMIUM ANTICAVITY 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68747-6038
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL  
    SILICON DIOXIDE  
    WATER  
    GLYCERIN  
    POLYETHYLENE GLYCOL 1500  
    SODIUM LAURYL SULFATE  
    TITANIUM DIOXIDE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    CARRAGEENAN  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE  
    SACCHARIN SODIUM DIHYDRATE  
    SODIUM BENZOATE  
    SODIUM PYROPHOSPHATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (MINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68747-6038-1 24 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR 01/01/2013
    Labeler - Dabur India Limited (650319218)
    Establishment
    Name Address ID/FEI Business Operations
    Dabur India Limited 650599231 MANUFACTURE(68747-6038)
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