Label: CINNAFRESH- sodium fluoride gel, 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 22, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

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

  • Purpose

    Anticavity toothpaste

  • Use

    Helps protect against cavities.

  • Warnings

    Keep out of the 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 immediately.

  • Directions

    Adults & Children 6 years of age & older:Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    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 ingredients

    Water, Sorbitol, Sodium Lauryl Sulfate, Carbomer, Sodium Saccharin, PEG – 40 Hydrogenated Castor Oil, Sodium Hydroxide, Sodium Benzoate, Flavor, FD&C 40

  • SPL UNCLASSIFIED SECTION

    Dist. by Bob Barker Co. Inc. Fuquay-Varina, NC 27526

  • PRINCIPAL DISPLAY PANEL - 24 GRAM Tube Label

    CinnaFresh®
    anticavity gel toothpaste

    Sodium Fluoride 0.22%
    Bold Cinnamon Flavor

    NET WT. 0.85 OZ
    (24 GRAMS)

    PRINCIPAL DISPLAY PANEL - 24 GRAM Tube Label
  • INGREDIENTS AND APPEARANCE
    CINNAFRESH 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53247-120
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53247-120-0124 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2008
    Labeler - Bob Barker Company Inc. (058525536)
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