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

FRESHMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [NEW WORLD IMPORTS, INC]
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NDC 51824-066-25, 51824-066-28
Set ID fd92c8b3-29dc-4a4b-b12c-fa6451d46b78
Category HUMAN OTC DRUG LABEL
Packager New World Imports, Inc
Generic Name
Product Class
Product Number
Application Number PART355
  • ACTIVE INGREDIENT

    Sodium Fluoride - 0.243%  (0.11% 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 under 6 years of age.  If more than used for brushing is accidentally swallowed, get meidcal help or contact a Poison Control Center right away.

  • 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 Sulfate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipiated Silica, Sodium Carboxymethyl Cellulose, Methylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    FRESHMINT 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-066
    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
    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:51824-066-287.9 g in 1 PACKET; Type 0: Not a Combination Product08/08/2018
    2NDC:51824-066-2571 g in 1 TUBE; Type 0: Not a Combination Product08/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/08/2018
    Labeler - New World Imports, Inc (075372276)

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