Label: FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE- fluoride toothpaste 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 August 25, 2008

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  • SPL UNCLASSIFIED SECTION

    NET WT. 6.4 OZ

    (181 GRAMS)

  • DRUG FACTS:

  • ACTIVE INGREDIENT

    Sodium fluoride - 0.22% (0.1% w/v fluoride ion)

  • PURPOSE

    Anticavity.

  • USE

    Helps protect against cavities.

  • WARNINGS

    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 right away.

  • DIRECTIONS:

    Adults & Children 6 years of age & 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 or physician.

  • INACTIVE INGREDIENTS

    Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, Propyl Paraben.

    Product of India
    Exclusive Distributor
    New World Imports, Inc.
    160 Athens Way
    Nashville, TN 37228.

    Expires: 3 years from the Date of Mfg.

    C. No. DNH/COS/DNH/52Mfg.
    Date & Batch No. on crimp.

    24.06.2009
    FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE

    ACTIVE INGREDIENT: SODIUM FLUORIDE - 0.22 %
    (0.1% w/v fluoride Ion)

    SR. NO. INGREDIENTS

    1. Treated water
    2. Sorbitol
    3. Carbopol
    4. Sodium lauryl sulphate
    5. Flavor
    6. Polyethylene glycol 1500
    7. Sodium saccharin
    8. Precipitated Silica
    9. Sodium Carboxy Methyl Cellulose
    10. Methyl Paraben
    11. Propyl Paraben
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Tube Label

    freshmint®

    ANTICAVITY FLUORIDE GEL TOOTHPASTE
    NET WT. 6.4 OZ
    (181 GRAMS)

    Tube Label
    Tube
  • INGREDIENTS AND APPEARANCE
    FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE 
    fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6027
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68747-6027-1181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/25/2009
    Labeler - Dabur India Limited (650319218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dabur India Limited650319218MANUFACTURE
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