FRESHMINT ANTICAVITY FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [NEW WORLD IMPORTS, INC]

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FRESHMINT ANTICAVITY FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [NEW WORLD IMPORTS, INC]
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NDC 51824-068-01, 51824-068-02, 51824-068-03, 51824-068-04, 51824-068-05, 51824-068-06, 51824-068-07
Set ID 2fa21cac-e71e-4bda-93ac-b5672d2d5095
Category HUMAN OTC DRUG LABEL
Packager New World Imports, Inc
Generic Name
Product Class
Product Number
Application Number PART355
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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Anticavity

  • 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.

  • INDICATIONS & USAGE

    Helps protect against cavities

  • WARNINGS

    Keep out of reach of children.

  • 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

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    Clear Gel Tube

  • INGREDIENTS AND APPEARANCE
    FRESHMINT ANTICAVITY FLUORIDE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-068
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2.2 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:51824-068-017.9 g in 1 PACKET; Type 0: Not a Combination Product09/17/2010
    2NDC:51824-068-0217 g in 1 TUBE; Type 0: Not a Combination Product09/17/2010
    3NDC:51824-068-0324 g in 1 TUBE; Type 0: Not a Combination Product09/17/2010
    4NDC:51824-068-0443 g in 1 TUBE; Type 0: Not a Combination Product09/17/2010
    5NDC:51824-068-0578 g in 1 TUBE; Type 0: Not a Combination Product09/17/2010
    6NDC:51824-068-06130 g in 1 TUBE; Type 0: Not a Combination Product09/17/2010
    7NDC:51824-068-07181 g in 1 TUBE; Type 0: Not a Combination Product09/17/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/17/2010
    Labeler - New World Imports, Inc (075372276)
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