Label: FRESHMINT ANTICAVITY FLUORIDE- sodium fluoride gel, dentifrice

  • NDC Code(s): 51824-068-01, 51824-068-02, 51824-068-03, 51824-068-04, view more
    51824-068-05, 51824-068-06, 51824-068-07
  • Packager: New World Imports, Inc
  • 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 November 1, 2018

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  • ACTIVE INGREDIENT

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

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  • PURPOSE

    Anticavity

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children 6 years of age.  If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    Helps protect against cavities

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  • WARNINGS

    Keep out of reach of children.

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  • DOSAGE & ADMINISTRATION

    Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each mean 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

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  • INACTIVE INGREDIENT

    Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipiated Silica, Sodium Carboxy Methyl Cellulose, Methylparaben, Propylparaben.

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  • INGREDIENTS AND APPEARANCE
    FRESHMINT ANTICAVITY FLUORIDE 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-068
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor MINT (Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-068-01 7.9 g in 1 PACKET; Type 0: Not a Combination Product 09/17/2010
    2 NDC:51824-068-02 17 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010
    3 NDC:51824-068-03 24 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010
    4 NDC:51824-068-04 43 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010
    5 NDC:51824-068-05 78 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010
    6 NDC:51824-068-06 130 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010
    7 NDC:51824-068-07 181 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/17/2010
    Labeler - New World Imports, Inc (075372276)
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