Label: FRESHDENT CAVITY PROTECTION ANTICAVITY- sodium monofluorophosphate 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 November 6, 2014

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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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