FRESHDENT CAVITY PROTECTION ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [FRESHDENT LLC]

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  • FRESHDENT CAVITY PROTECTION ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [FRESHDENT LLC]

FRESHDENT CAVITY PROTECTION ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [FRESHDENT LLC]
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NDC 69338-002-01
Set ID 16ac653c-0bad-4d3b-a060-1be1444f28af
Category HUMAN OTC DRUG LABEL
Packager FreshDent LLC
Generic Name
Product Class
Product Number
Application Number PART355
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  • Active Ingredients

    Sodium Monofluorophosphate 0.76% (0.085% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

  • Keep out of Reach of children

    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 and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

    • Children under 2 years of age: Consult a dentist or doctor.
  • Inactive Ingredients

    Sorbitol, Water, Hydrated Silica, Calcium Carbonate, Sodium Lauryl Sulfate,Carboxymethyl Cellulose, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Methyl Paraben, FD&C Blue 1.

  • Questions?

    +1-512-653-8814

  • Package Label

    Anticavity Toothpaste

    FreshDent          

    we care      

    Cavity Protection

    Strengthens teeth with Active Fluoride

    Net Wt. 0.85 oz (24 g)

    Distributed by: FreshDent LLC Crockett, TX 75835 www.freshdent.net Made in Egypt

    CavityBoxCavityTube

  • INGREDIENTS AND APPEARANCE
    FRESHDENT CAVITY PROTECTION ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69338-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.85 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69338-002-011 in 1 CARTON
    124 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/06/2014
    Labeler - FreshDent LLC (079303265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss Egyptian Co. For Oral Care Products and Cosmetics366442234manufacture(69338-002)
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